Editorials

Our democratic processes have moved on — so must our science In April 2007, Victoria became the first Australian state to enact legislation (the Infertility Treatment Amendment Bill 2007) that followed the passage by federal Parliament in December 2006 of the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 (Cwlth). This Act gave effect to most of the recommendations of the Legislation Review Committee, chaired by the late John S Lockhart, which reported in December 2005. The Lockhart Committee engaged in wide community consultation and considered expert advice from many sources before making its recommendations on what was inevitably an issue arousing passionate public debate. Similar intense debate had crossed party lines in both federal and Victorian Parliaments, but with a “conscience vote” in both houses in each instance (allowing members to vote as they personally wished rather than along set political party lines), legislation was passed containing major provisions for strict regulation of all aspects of research involving human embryonic material and the strict prohibition of human cloning for reproductive purposes — with draconian penalties for transgression. Many other prohibitions set out in the previous Research Involving Human Embryos Act 2002 (Cwlth) have been firmly retained. Similar legislation has now passed both houses of the New South Wales Parliament, following vigorous public controversy over the respective roles of the legislature and of the Catholic church on the issue. Corresponding legislation is expected to be considered in other states and territories, as Australia moves to permit further progress in this critical and fast-moving area of scientific development. Legislative protection from both federal and state governments allows greater freedom in the quest to understand disease mechanisms by studying stem cells containing abnormalities underlying genetic disorders, and the development of new approaches to treatment of hitherto unyielding diseases. The new science of regenerative medicine can move ahead in Australia, with the research and technological developments now permitted having great implications for human medicine. A new international system for collaboration in this important field is also emerging.1 Human embryonic stem cell lines were first created in 1998 from blastocysts;2 the techniques used were based on at least a decade of research on mouse embryonic stem cells. The key characteristic of embryonic stem cells, not shared with adult stem cells, is their capacity for long-term or immortalised culture, permitting extended research and growth of the large number of cells necessary for human implantation. The process of somatic cell nuclear transfer allows human embryonic stem cells to contain the nucleus of the recipient cell, so an individual’s immunological constitution will be conferred to the stem cell and its progeny. Technological developments to date have included: Better methods for growth and maintenance of human embryonic stem cells in vitro, including Good Manufacturing Practice (GMP) compliance and industrial scale production; Better methods to more reliably drive embryonic stem cells along particular cell and tissue pathways; Differentiated embryonic stem cell progeny have been used for drug screening and toxicology testing; Demonstration of the medically relevant capabilities of human embryonic stem cells in animal models; and Isolation of new embryonic stem cell lines and creation of collaborative cell banks and networks. Regulatory compliance still presents challenges, as expected of any living-cell therapy. The potential applications to human disease are many, as shown by real advances made recently with human diseases in animal models. Studies transplanting cells derived from human and monkey embryonic stem cells into animal models have shown correction or partial correction of Parkinson’s disease.3,4 Growth of cardiac myocytes derived from human embryonic stem cells has been demonstrated in pigs, with correction of electromechanical function;5 human embryonic stem cell-derived oligodendrocytes have improved spinal cord injuries in rats;6,7 and human embryonic stem cell-derived islet cells have functioned in animals with diabetes.8 However, regenerative medicine in human subjects using transplanted stem cells or their progeny faces three serious technical hurdles: Transplant rejection (and the monitoring of this); Efficient guidance of embryonic stem cells down correct pathways of differentiation using growth factors; and Ensuring cells of such great proliferative potential do not, on rare occasions, develop into cancers. Strongly held views in the community on all aspects of research involving human embryonic stem cells must be acknowledged. Similarly, unrealistically high hopes for rapid advances in developing new treatments for distressing and debilitating diseases fail to grasp the long lead times that inevitably apply; medical practitioners will probably be asked for their advice on such matters. Our democratic processes have moved on — so must our science. It is important to recognise that there will continue to be strict regulatory oversight of all research involving human embryonic stem cells, and regular reviews of progress will be important.

David G Penington AC · Graham F Mitchell AO

CABG offers a cost-effective and better long-term clinical outcome for many patients Coronary artery disease is still the single largest cause of premature death in Australia, according to the Australian Institute of Health and Welfare.1 Also documented is the dramatic decline in age-related mortality from heart disease, which is largely attributed to reductions in smoking and better intervention for hyperlipidaemia and elevated blood pressure.2 As many as 85% of elective percutaneous coronary intervention (PCI) procedures are done in patients with stable coronary artery disease.3 However, the only data showing prognostic benefit of intervention in reducing death and infarction in such patients come from subgroup analyses in old surgical trials,4-6 which showed benefits for patients with left main, triple vessel or proximal left anterior descending stenoses, especially if there was additional left ventricular damage. These benefits lasted up to 11 years, but the surgery was compared with medical therapy that did not include aspirin, β-blockers or lipid-lowering therapy for most patients. The surgical group did not receive arterial conduits. Subsequently, 11 randomised trials comparing PCI with coronary artery bypass graft (CABG) surgery for patients with multivessel coronary artery disease showed that the frequency of death and myocardial infarction was similar in both arms.7 These results cannot be used to claim an outcome benefit for PCI, as the trials entered only about 5% of screened patients, and the patients were not equivalent in the severity of their coronary artery disease to those in the original CABG trials. Further, analysis of the comparative trials shows that the highest-risk group (those with diabetes) showed benefit with CABG over PCI.8 Outcomes after CABG now show that, despite this surgery being performed in increasingly sick and complex patients, the overall mortality is less than 2%.9 Average length of hospital stay is now 3–5 days and return to work is usual in less than 2 months. Improved techniques have reduced the problem of cognitive impairment, and comparative studies have shown no difference with PCI in this respect.10 Long-term outcomes of CABG have improved due to the increased use of arterial conduits. Repeat CABGs now make up only 3%–4% of total CABG surgery, although this low figure may reflect a preference for PCI in repeat procedures. PCI has flourished since its introduction 30 years ago, with its offer to patients of a sound and timely intervention for coronary artery disease — but it has not been without problems. Recoil restenosis with balloon angioplasty was largely solved by the introduction of bare-metal stents. Acute stent thrombosis is less of a problem with better anticlotting agents, and drug-eluting stents have significantly reduced the problem of late restenosis. Despite these improvements, no reported studies have shown convincing evidence that PCI reduces the finite end points of death or myocardial infarction for patients with stable coronary artery disease. Controversy has recently arisen over the finding that patients with drug-eluting stents have an ongoing excess risk of late stent thrombosis of around 0.5% a year, presumably due to failure of endothelialisation of the stent. These events are usually associated with acute myocardial infarction, which carries a 50% mortality rate. It is now recommended that patients with drug-eluting stents stay on combined treatment with clopidogrel and aspirin for at least 12 months after implantation, and possibly permanently.11 This adds to patients’ financial costs and places them at extra risk of bleeding. Two recent reports provoke additional comment. First, Griffin et al used a complicated analysis of previous data to assess the cost-effectiveness of PCI and CABG in patients with multivessel disease considered suitable for revascularisation. CABG reached the accepted level of cost-effectiveness (US$60 000 per quality-adjusted year of life gained) but PCI did not, mainly due to the ongoing need for repeat procedures in PCI patients.12 Second, Boden et al reported a randomised trial comparing PCI with medical therapy in patients with stable coronary artery disease, which found no difference in the rate of death or non-fatal myocardial infarction at a median follow-up of 4.6 years. The PCI group initially had a reduced rate of angina, but this difference had disappeared at 5 years, largely because the medical therapy group had improved.3 The best interpretation of currently available data is that, for patients with severe coronary artery disease, the more invasive procedure with a longer recovery time (CABG) has a better long-term clinical outcome and is more cost-effective than the less invasive fast-recovery procedure (PCI). Three ongoing randomised clinical trials (CARDia, SYNTAX and FREEDOM) should further clarify the roles of PCI and CABG in treating severe coronary artery disease. The question then arises of whether, in current practice, PCI is being used in patients with severe coronary artery disease who would be more appropriately treated with CABG. Surgeons and cardiologists have argued that patients are not being adequately advised of the surgical option.13 Indeed, use of CABG is in such decline that training programs for young surgeons are at risk.14 In practice, the patient decides between CABG and PCI following discussion with a cardiologist, often while still in the angiography suite. This arrangement bypasses one of the recommendations on self-referral issues: to undertake consultation with other providers.15 It has been suggested that the technical suitability of a lesion for angioplasty determines the advice given to patients, rather than the relative benefits of CABG, PCI or even medical treatment alone.16 Smoking cessation and treatment to lower lipids and blood pressure are remarkably effective in improving the outlook for patients with stable coronary artery disease. Both CABG and PCI will provide benefits if revascularisation is performed for relief of symptoms, and patients may be influenced in their choice by both the less invasive nature of PCI and by the fewer recurrent procedures offered by CABG. However, for patients with prognostically important stable coronary artery disease (ie, severe left main or triple vessel disease), current evidence indicates that CABG offers a better long-term outcome.

Keith V Woollard MRCP, FRACP · Mark A J Newman DS, FRACS

The time to make it happen is long overdue There is a tide in the affairs of men, Which, taken at the flood, leads on to fortune; Omitted, all the voyage of their life Is bound in shallows and in miseries. William Shakespeare, Julius Caesar Australian medical education is facing a crisis of unforeseen proportions. This crisis will not only affect the quality of the education of future medical students but may also impact on their opportunities for vocational training. In essence, there is a mismatch between future demands for quality medical education and the capacity of the health care system to support this in both the undergraduate and postgraduate years. The immediate precipitant of this looming crisis is the recent undisciplined and poorly planned increase in medical school numbers. In response to projected medical workforce shortages (a predicament of the government’s own making), the Australian Government, in rapid succession, announced the establishment of seven new medical schools. The increase in medical school places was further augmented by a relaxation of the restrictions on local and international full-fee-paying students. From 2005 to 2012, the number of annual domestic graduates will increase by 81% (from 1348 to 2442), and the number of international graduates will nearly double (from 260 to almost 500).1 There will be at least 12 000 students in the system at any given time, and around 3000 will graduate each year. While the increase in medical school places is obviously welcomed, where are the educational resources to accommodate these student numbers? And, more importantly, will quality teaching and learning be sacrificed? The demand for an expansion of educational capacity comes at a time when teaching hospitals are losing their value and status as educational powerhouses.2 The reasons for this are diverse and complex, but include: the diminishing numbers of hospital beds; shorter lengths of stay for patients; a move to day-only admissions for surgical patients;3 and and the increasingly complex conditions of hospital patients, compared with those seen in primary care.2 Added to this litany of problems are the difficulties experienced by students in seeking access to patients in the hospital setting.4 As a consequence of these developments, there has been a reemphasis on involving general practice in medical education.5,6 This issue of the Journal features a number of articles exploring diverse issues related to this task. Thistlethwaite et al argue the case for general practice becoming a leading provider of medical education in the 21st century;7 Pearce et al expose the challenges involved in teaching in general practice;8 and Dick et al emphasise the importance of vertical integration in general practice-based medical education.9 Finally, Jackson and Marley present accounts of two established academic general practices, which may prove useful models for general practices involved in teaching.10 Other Australian models also exist, such as Lubims Inc, a not-for-profit Family Practice Network owned and operated through a trust by the University of Adelaide. However, whatever the model, we will need upwards of 500 new teaching general practices across Australia (Professor Justin Beilby, Executive Dean, Faculty of Health Sciences, University of Adelaide, personal communication). One intriguing outcome of all these developments is that this trend may well support a renaissance of general practice, which, sadly, has often been the target of negativism by both general practitioners and specialists alike.11,12 Furthermore, compared with general practitioners, doctors in teaching hospitals undoubtedly benefit from a profound professional advantage, which flows from the academic ambience and collegiality of their workplace; their ability to shape the learning and interests of young minds; and the institutional infrastructure that provides manifold opportunities for research. However, it can be argued that all these advantages and attributes can easily be replicated in general practice, if it is given appropriate infrastructure and funding. Importantly, the realisation of increased teaching in general practice should not depend on yet another series of temporising governmental inquiries. The time has come for a national taskforce to make it all happen — and happen soon! The Flexner Report of 1910, which provided the foundations of modern medical education, also arose from a crisis: community disquiet in the United States at the end of the 19th century over the quality of medical practice and practitioners. This crisis also had its origins in medical education — in the mediocre quality of many North American medical schools, with their inadequate curricula, atrocious facilities and their rapacious focus on profits.13 In response to this crisis, the American Medical Association (AMA) carried out an inspection of North American medical schools in 1906 and uncovered widespread deficiencies in teaching, and unacceptable profiteering. The report was not published, as it was deemed imprudent for a medical organisation such as the AMA to be critical of medical schools.13 However, the AMA invited The Carnegie Foundation for the Advancement of Teaching to look into the matter, and the outcome was the Flexner Report. Its recommendations for reform were widely accepted as principles for governing medical schools,13 and they are equally relevant for medical education in a community setting today. Firstly, Flexner urged that teaching should be equipped with appropriate infrastructure and funding; secondly, that the teachers must be adequately trained; and thirdly, that research should be a central activity, integral to and informing all medical practice. In practice, this means modern and appropriate facilities, good teachers, a university affiliation, and a commitment to excellence in research and care; in short, general practice with TLC — Time for teaching, Learnedness in the art and science of teaching, and a Commitment to teaching the next generation of young doctors the art and science of medicine. The national taskforce for implementing an expansion of teaching in general practice should not inadvertently “throw the baby out with the bathwater”. Obviously, there will continue to be a need for teaching hospitals, but these should be better configured, with closer ties to the general practice community, allowing students to follow patients on their journeys from the community to hospital.14 In keeping with a recommendation of the recent Productivity Commission report on Australia’s medical workforce, support for this taskforce should be provided by the Australian Government Department of Health and Ageing.15 Also in this issue of the Journal, Scott and Coote present their analysis of performance outcome measures pertaining to the Divisions of General Practice.16 The relevance of their findings is further developed by Sprogis.17 Both these contributions raise questions as to whether the Australian Government (and indirectly the community) obtains value for its not inconsiderable financial support of the Divisions. Could not all or a considerable proportion of this money be more profitably diverted to provide educational infrastructure in Australian general practices, using the models described by Jackson and Marley,10 or strategically located general practice teaching centres with a “hub and spoke” configuration linking with other local general practices and hospitals, as proposed by Douglas and his colleagues almost 15 years ago?18 Back then, the suggestion apparently fell on deaf ears, but maybe with the looming crisis in medical education, its time has come. At the very least, the teaching-in-general-practice movement should be able to capitalise on the developed infrastructure and facilities of the Divisions and of the General Practice Education and Training program. The fulfilment of general practice as a major provider of medical education remains an exciting and challenging task — and its realisation may well mean a continuing renaissance of Australian general practice.

Martin B Van Der Weyden MD, FRACP, FRCPA

It is a national disgrace how little is known about the impact of the Divisions after 15 years In this issue of the Journal, Scott and Coote provide an important contribution to a better understanding of one of the more significant Australian health policy changes of the past 20 years: the Divisions of General Practice (→ Wither Divisions of General Practice? An empirical and policy analysis of the impact of Divisions within the Australian health care system).1 Why this article is so significant in policy impact terms is that, according to the Australian Government: The Divisions network is Australia’s largest representative voice for [general practitioners] and provides local support to general practice. Divisions perform a range of activities to improve and address access, integration, chronic disease management, workforce issues and consumer needs.2 This makes the Divisions the third component of the Australian national organised health care system, the other two being the public health/hospital and private insurance sectors. It is therefore a national disgrace how little is known about the impact of the Divisions of General Practice after 15 years of operation. It is in this context that the article by Scott and Coote is so critical. A unique and key feature of the Divisions is that they are GP member owned and operated, regional health care organisations. This private ownership by a medical professional grouping is a unique approach to a national health structure, and is unlikely to be emulated by any other medical or allied health specialty group in the future. The Divisions have been allocated further core funding, as noted in the recent Australian Government budget papers: The Government will provide $243.3 million over three years from 2008–09 to continue funding the Divisions of General Practice network. The objective of the network is to promote the health and wellbeing of Australians by working with general practitioners and other health service providers to improve the quality and accessibility of health care at the local level. The programme also provides an important avenue for the support and delivery of Government programmes.3 Additional funding from various state governments and other sources is now growing more rapidly than the core Australian Government funding. My Division, the Hunter Urban, is a typical Division with more than 10% of local GPs having participated in a leadership role at board level over the 15 years. The Division serves a population of more than 400 000, with over 420 GP members; more than 90% of GPs participate in any divisional service or clinical activity and 80% of GPs were involved in more than five service or clinical activities in 2006. The range of activity is very broad, and encompasses funding from over 10 different sources (both public and private), a budget of more than $10 million (of which Australian Government core funding is about $1.5 million), and services across a significant spectrum of GP activity, including practice infrastructure support.4 However, the burning question for 15 years has been, and continues to be, what do Divisions do and, more importantly, what impact do they have? Are taxpayers receiving value for their investment? What should that value look like and how might it be quantified? The study by Scott and Coote involved “Regression analysis using longitudinal data across Australia”,1 and the first question it raises is why was such a complex tool necessary? A more conventional organisational analysis using targets and benchmarks set by the main funder (the Australian Government) should have been possible, particularly where a cumulative total of $2 billion or more of taxpayer funds have been expended over 15 years. Unfortunately, as the authors have noted, these data simply do not appear to exist — certainly not in readily analysable form. Despite a major review of the Divisions undertaken in 2002–2003,5,6 which made recommendations related to the need for clarity in measuring performance and for a rigorous evaluation process, in 2006–07, the Divisions’ goals for core funding from the Australian Government remain couched in vague terms. In 2006–07, the agreement between the Australian Government and the Divisions, known as the Multi Program Funding Agreement, has a set of overall goals (Australian Government, Agreement plan for the funding period annual plan 07/08). These include: Governance: organisational capability, financial accountability, and governance; Prevention and early intervention: focus on prevention and early intervention; Access: improve access; Integration: encourage integration and multidisciplinary care; Chronic disease: better manage chronic conditions; General practice support: support GPs and general practices within a changing primary care environment; Quality support: support quality and evidence base; Consumer focus: ensure a growing consumer focus; and Workforce: support the recruitment and retention of an appropriate primary care workforce. The only clearly specified funding-dependent target is organisational (organisational accreditation), with few other clearly targeted benchmarks for health or service outcomes. This lack of specificity in targeted outcomes is not unique to Divisions as, for example, an examination of the private health insurance sector (with an annual government subsidy expenditure in 1 year greater than Divisions over 15 years) also demonstrates how widespread the absence of service and health outcome data is. So what does the article by Scott and Coote reveal and, particularly, what does it not reveal? They report that Divisions have a positive effect at the infrastructure and organisational level and, in the absence of any other equivalently rigorous research, this now represents the best evidence we have for some aspects of the utility of Divisions of General Practice in 2002–2004. In an environment where workforce shortage and lack of patient access is a key issue, with improvements in infrastructure being seen as one of the main solutions, then the inference from the article is that Divisions should be increasingly funded to tackle the infrastructure and organisational deficits within general practice. Critical to the analysis of the Divisions, and acknowledged by Scott and Coote, is that “Only a relatively narrow range of Divisions’ outputs and primary care performance was examined, because of a lack of data”.1 This lack of outcome measures clearly is an indictment of the lack of responsibility the government and its agency, the Department of Health and Ageing (DHA), take in monitoring their own performance as administrators of community resources. It represents an accountability deficit at government level. What is puzzling is that, in other DHA-administered program areas, there are clear, simple and effective measures of performance. This does not seem to extend to the Divisions program. Service delivery forms a major part of the activity of many Divisions, particularly in rural areas. For example, under the More Allied Health Services program, rural Divisions are often the major or only suppliers of these services to their rural communities. As another example, in my region, the Hunter Urban Division is the default provider of ambulatory after-hours GP services, with more than 100 000 patient interactions each year delivered by more than 250 GPs and 60 nurses. Service delivery, as acknowledged by Scott and Coote, is the most rapidly growing part of divisional activity, and the relationship between Divisions and service provision needs something better than a “lack of data”, which implies a lack of performance indicators and targeted benchmarks to define its worth. My experience has been that individual Divisions and their peak bodies have been ready, willing and able to set and meet specific targets and it is the Australian Government and its bureaucracy that apparently is struggling with this facet of accountability. So, where to from here? The first step is not more studies using regression analysis or research involving experimental and control groups. Australia has had far too much policy by trials (a phenomenon internationally unique to Australian health policymakers and their bureaucracies). If, as I and many others believe, Divisions are the greatest single, positive, underutilised organisational health resource in our nation, and funding should match their potential for a much larger role in primary care health service delivery, then policymakers and governments need to put this to the test by establishing clear goals, with attached performance measures and targeted benchmarks that are open and transparent to all. We all have a right to see if what appears to be true is based on empirical evidence. It might well set an example for other health policy initiatives, which would have to meet the same challenge: transparent accountability to the Australian community. The article by Scott and Coote is a step in the right direction.

Arn Sprogis MB BS, FRACGP, GradDipClinEpid

The time has come to review and reflect on where these reforms are meant to be leading There is now a plethora of new Medicare Benefits Scheme (MBS) item numbers encompassing chronic disease management, diabetes annual cycle of care, asthma cycle of care, 45-year-old health check, health assessments for older people and refugees, general practitioner mental health care, pregnancy support counselling service, and domiciliary medication management reviews. The availability of these item numbers would appear to be logical, as they are linked to important national policy initiatives such as the National Chronic Disease Strategy,1 Australian Better Health Initiative,2 and the National Mental Health Strategy.3 However, of increasing concern is that, with each budget cycle, another layer of new MBS item numbers is added. There is little clarification of what the final end point of these reforms will be. If the goal is a strong, robust and integrated primary care system4 that will deliver improved outcomes for these patient groups, then using the rather crude tool of successive new MBS item numbers alone is unpredictable5 and is likely to provide only part of the solution. There is a paucity of published evidence that the new MBS item numbers have improved patient care. Some improvements in patients with diabetes have been noted,6,7 and smaller studies have found positive changes in referrals to allied health professionals due to the use of care plans.8 In a review of information technology and health, Georgeff cited evidence that “less than 14% of patients with chronic disease are placed on care plans” and less than 1% are followed to see if patients adhere to these plans.9 In this issue of the Journal, Hickie and McGorry query the geographical distribution of the uptake of the mental health items, the out-of-pocket expenses for patients referred, and the possible absence of focus on the highest risk groups (→ Increased access to evidence-based primary mental health care: will the implementation match the rhetoric?).10 They suggest that the uptake is in groups who were already accessing psychological support services.10 Another study found further evidence regarding the lack of equity in use of health assessments.11 It is an indictment of the health bureaucracy that no systematic evaluation has been established to formally assess the effect of these new MBS items. Earlier evaluations for the original enhanced primary care item numbers12 and asthma Service Incentive Payment (SIP) item number13 have resulted in constructive innovations. If the overall aim is an integrated general practice that can manage the burgeoning number of patients with these conditions, then it is important to gather evidence to support this hypothesis. Over the period from July 2005 to June 2006, the number of health assessments claimed for was 285 861; care plans and case conferences, 1 234 703; GP diabetes, asthma and mental health items, 249 620; and the use of psychological strategies, 30 261.14 This is about 2% of the 90 million patient consultations completed over this period. Yet we do not know the patient impact and cost-effectiveness of these activities. GPs are voting with their feet and continuing to focus on the core of general practice — the consultation. Red tape, GP workforce shortages and the paucity of trained allied health professionals have been regularly cited as causing the lack of uptake of these items.15 Jurisdictional differences between state, territory and federal governments also continue to surface as key barriers for evidence-based health policy. Also in this issue of the Journal, Harris and Zwar outline concerns with chronic illness (→ Care of patients with chronic disease: the challenge for general practice),16 arguing that these new chronic disease items are only part of a fully functional chronic disease model. The complete model would include:17 clinical information systems that measure quality of care; actively implemented decision support and guidelines; ongoing information management and data exchange; integrated chronic condition self-management programs; appropriate finance systems; practice-based teams; and community and consumer linkages. The only elements being fully supported by the new MBS items are the final two. The principal policy response seems to be to add new MBS item numbers and then hope that Australian general practice can adapt and deliver the required outcomes. There are no regular programs to consult on or support the development of the other elements. The way forwardThe time has come to halt this approach to the MBS and review and reflect on where these reforms are meant to be leading. We need a better system. Following are some of the elements this system should include. Developing an articulated vision for general practice and primary careThe reforms1-3 that underpin these new MBS items require more than item numbers. A vision that is accepted by all groups, with agreed goals, effective leadership and alignment across all governments and local non-government providers, is vital if these reforms are to deliver the desired outcomes. Methods of increased accountability that foster quality and accessibility for all groupsModels that “reward practices for delivering clinical and organisational quality”, such as in the United Kingdom,18 need exploring. Since 2004, general practices in the UK have been given the opportunity to receive extra funding for achieving a range of specific standards in clinical areas (eg, stroke, diabetes, and asthma), practice organisation (eg, information for patients), patient experience, and additional services.18 In a similar way, Australian general practices should be financially rewarded with extra payments for reaching agreed practice-based targets for health assessments, diabetes SIP, and GP chronic disease items. This model would need to be supported by ongoing practice-based audits, which could be implemented by the Divisions of General Practice. Supporting longer consultationsA debate is required about whether a financial model that rewards GPs for spending more time with the patients would achieve as much as the plethora of new item numbers.19 Improving the infrastructure to foster the use of shared e-health recordsIt has been calculated that $1.5 billion could be saved by “improved knowledge sharing and care plan management”.9 Providing financial incentives to all GPs and allied health providers to foster the use of shared records with the electronic delivery of referrals and discharge summaries is a logical initial first step.9 Improving the flexibility of delivery of chronic disease programsFunding self-management programs,20 and allowing other allied health groups to instigate multidisciplinary care plans and establish the primary care teams in partnership with general practice are other options. The health priorities that underpin the MBS item evolution will not disappear. They will only increase and we have a pressing need to find solutions that will provide sustainable and acceptable solutions. But the time to gather evidence for effectiveness and efficacy is long overdue.

Justin J Beilby FRACGP, DRCOG, DA

Increasing the number of “special interest” GPs may exacerbate the current GP shortage According to the Royal Australian College of General Practitioners (RACGP): In the provision of primary care, much undifferentiated illness is seen; the general practitioner often deals with problem complexes rather than with established diseases. The general practitioner must be able to make a total assessment of the person’s condition without subjecting a person to unnecessary investigations, procedures and other treatment.1 In this paradigm, a condition such as chest pain may have its roots in the physical, social and/or psychological domains, and a robust general practice system is crucial to managing these complex clinical interactions. A GP is well placed to determine the relative contributions of these causes and to effectively manage the interface between primary care and the hospital. Starfield and colleagues have long argued this case, and few have offered a cogent counterargument.2 However, in the United Kingdom, and now in Australia, a formal system of GPs with special interests (GPwSIs) — that is, GPs having a subspecialisation within general practice — is touted as the answer to the growing demand for specialist services in this issue of the Journal (page 111)3 and elsewhere.4 There is clear evidence of the value of subspecialisation in some areas of general practice — for instance, in Indigenous health, palliative care, drug and alcohol services, and HIV management.5 The case for expanding these roles to include yet more “special interests” is that the policy will “develop careers through offering additional interest, personal development and heightened self-esteem”.6 This may be a persuasive argument for increasing the attractiveness of general practice, where there is a growing manpower crisis and an urgent need for enthusiastic new recruits. However, this approach is also associated with a call for more “locums” to make up for manpower shortages in general practice and the deskilling of the GP pool in some clinical areas. Thus, diverting the GP workforce will compound shortages in “core general practice”. A key driving force behind the promotion of GPwSIs in the UK was the perceived need to reduce “inappropriate” referrals and hospital admissions, thereby improving the efficiency of health resource utilisation. However, referral processes in general practice are frequently complex and multifactorial, and are unlikely to respond to this approach.7,8 GPs may also be reluctant to refer to colleagues whom they perceive as generalists with much the same level of skill as their own.9 In other words, GPwSIs may offer an additional service rather than an alternative to specialist services. If GPwSIs were to reduce the workload for specialists, their impact on primary care could be unhelpful or even detrimental. In a recent UK patient survey, it emerged that patients foresaw difficulty making appointments with their chosen GP in circumstances where a special-interest GP was working at the practice.10 In the Australian context, it may be difficult to predict the likely impact, given that general practice is a privatised business. However, if such difficulties with access were mirrored here, the resulting loss of continuity of care could diminish the key value of the GP as defined by the RACGP. This is of special concern given the growing burden of chronic disease in an ageing population. Indeed, many patients are still receiving suboptimal care for chronic disease.11 Furthermore, with the increasing policy emphasis on prevention, screening and surveillance, many patients will need more access to GPs. To achieve the long-term benefits of these policy directions, we need to protect the principle of equal access for all. Patients in the UK, where the GPwSIs concept has been widely embraced, are impressed by the speed of access and personal aspects of the service, but not necessarily by its quality. In the UK, GPs-in-training have been reported to be naive about the potential complexities of accreditation and governance required for the roles of GPwSIs. If GPwSIs are to become a feature of the primary care landscape in Australia, appropriate training and accreditation will be critical to prevent them being regarded as a cheaper, second-class service. Another danger with facilitating growth in the number of GPwSIs is the possibility that it will interfere with the fabric of primary care — namely, an accessible, generalised, integrated and coordinated approach to patient management. Furthermore, we should not underestimate the financial incentive to dabble in lucrative specialist procedures in a largely unregulated health care system in which many GPs feel undervalued. Indeed, a more appropriate remunerative structure, especially for cognitive (as opposed to procedural) practice, may well serve to change perceptions of what is attractive and rewarding. Thus, promoting GPwSIs in Australia may serve only to redistribute scarce GP resources while running the risk of exacerbating GP workforce shortages. This, in turn, will require more GP training positions to be established, a decision that is not under the control of the profession. Balancing the increasing role of GPwSIs in Australian general practice will require careful workforce modelling and planning.

Moyez Jiwa MD, FRACGP, MRCGP · Hooi C Ee MB BS, PhD, FRACP · Justin J Beilby MD, MPH, FRACGP

Infection control principles need to be at the core of Australian hospitals, not just an afterthought Methicillin-resistant Staphylococcus aureus (MRSA) infections continue to be an entrenched problem in hospitals throughout Australia,1-3 and create an added burden for hospital care, rather than simply replacing infections caused by more antibiotic-susceptible bacteria. The cost of not dealing with MRSA, as is currently the case in most Australian states, appears to be huge, including prolonged patient length of stay and reattendances to outpatient clinics, not to mention the suffering of affected patients. Yet many in the health sector feel overwhelmed by the MRSA problem, and see it as a part of life about which little can be done. We believe this is a faulty assumption — it is possible to make an impact. In some countries (eg, Denmark and the Netherlands), where “search and destroy” campaigns have been implemented, MRSA has been kept at very low levels in hospitals.4,5 In Western Australia, infections caused by multiresistant strains of MRSA in hospitals remain uncommon, partly due to screening and isolation of patients transferred from endemic areas, such as the eastern Australian states.6 In Brisbane, marked reductions of MRSA occurred when major hospitals were refurbished and more vigorous infection control programs introduced.3 In Victoria, significant reductions in hospital MRSA infections have been achieved by introducing better hand hygiene practices.2 We should not be surprised that bacteria such as S. aureus have learned to adapt and survive in the antibiotic-rich environment of a modern hospital. Ultimately, we cannot avoid the Darwinian principle of natural selection and thus will always need new antibiotics. However, we also need to consider another unavoidable principle, not from evolution, but from history: when you crowd sick or stressed people together, epidemics are likely to emerge. Military history is replete with examples of disease outbreaks in the crowded ranks causing more damage than the enemy itself. Australia is “at peace”, yet we have overcrowded emergency departments, where rows of casualties wait endlessly for a bed in the completely full hospital — making our hospitals resemble war zones! This crowding results in worse outcomes for patients.7 How many Australian health care workers and students, all with varying goals and agendas, understand and practise infection control principles well enough to protect their patients from cross-infection? What about the patient’s agenda — getting better and getting home without a hospital-inflicted wound or complication? Clearly, we who work in hospitals can and should improve our act. However, regardless of how much we improve our personal infection control practices, there is still an irreducible philosophical tension between an economist’s model and an ideal hospital. Our current hospital system seems to be run predominantly with reference to economic outcome measures — more and more throughput, same staff numbers, but with older and sicker patients. We need hospitals to be built and managed so that infection control is their main priority. Somewhere between our current reality and the dream of infectious diseases physicians, a new balance needs to be reached. What do we need to do?We already have numerous guidelines — we need to follow them. Recently, the “Protecting 5 million lives from harm” campaign again highlighted many of the crucial issues.8 Leadership is needed, in hospitals and at the state and national levels. We need basic infection control practices to be followed by all clinical staff and students — in particular, hand hygiene. We can’t continue to accept that a good result is when 50% of staff comply. Enough equipment and supplies (eg, gloves, gowns) must always be available so that health care workers can comply easily. These workers also need backup, with adequate personnel in infection control, microbiology and environmental services. The basic components of any infection control campaign are: Hand hygiene — use of an alcohol-based hand rub, soap and water, and gloves; Decontamination of the environment and shared equipment; Contact precautions for infected and colonised patients; Active surveillance and screening; Effective programs that prevent common infections (eg, intravascular catheter sepsis, surgical site infections); Good antibiotic stewardship; and Better hospital design to include more single rooms for patients. To make these components work, we need staff in our hospitals to accept that MRSA causes needless morbidity and mortality, and to aim for a near-zero infection rate for health care-acquired infections. We need to accept that health care workers are key conduits for spreading MRSA. Staff can then make a major contribution to stopping its spread by adhering to basic infection control practices. Hospital managers and health departments are equally responsible for ensuring that people can do their jobs under reasonable working conditions. We need to recognise that MRSA is a signal that the system is stressed. We need to measure our successes and failures.9 Is it a coincidence that the state with the lowest prevalence of health care-associated MRSA (Western Australia) is also the only state in which MRSA infections are notifiable? We need better hospital design so that contact precautions and single-room isolation can be achieved. This means we need to insist, as is now recommended in many countries, that all new hospitals have nearly all patient accommodation as either single rooms or shared rooms with a maximum of two patients. Otherwise, how can adequate spatial separation of MRSA-colonised or infected patients be ensured? MRSA remains a scourge. Programs that effectively reduce the rate of MRSA infections in hospitals are well known, and some have been successfully implemented in Australia. For these to be effective, however, requires a culture change in the attitude of most Australian health care workers and a new era of government leadership in providing adequately resourced modern hospital facilities with infection control principles at the core of their design, not just added as an afterthought. A better understanding of MRSA and basic infection control issues is needed by the entire community (taxpayers, architects, engineers, health care workers, students, governments, administrators, and patients) if we are to ever finally control MRSA and other health care-associated pathogens.

Peter J Collignon FASM, FRCPA, FRACP · M Lindsay Grayson MD, FRACP, FAFPHM · Paul D R Johnson MB BS, PhD, FRACP

Unnecessary examinations expose patients to risk without benefit and are a threat to the effective allocation of resources Things aren’t as they used to be. Imaging investigations are replacing the old paradigm of history-taking, physical examination and provisional clinical diagnosis.1 We may blame intellectual laziness, but short consultation times in general practice, fear of litigation, and the expectations of patients all contribute to the burgeoning use of medical imaging. Unfortunately, a lack of understanding of the role of imaging in specific clinical situations leads to unnecessary imaging or imaging that is inappropriate in terms of timing or the choice of modality. The article by Simpson and Hartrick2 regarding requests for thoracic computed tomography (CT) scans by general practitioners has, by the authors’ own admission, certain shortcomings: for example, it was a retrospective study and the appropriateness of CT requests was judged on subjective criteria; the value of a negative test for exclusion of disease was understated (→ Use of thoracic computed tomography by general practitioners). Nevertheless, the article is a useful starting point for considering the problem of inappropriate imaging investigations in a wider context. Most radiologists are aware that diagnostic imaging is often inappropriately used. Perhaps up to a third of radiological examinations are totally or partially unnecessary.3 In 2002, Hammett and Harris4 suggested that it was time to reduce inappropriate test ordering, but there is little evidence of any change in practice since that time. Unnecessary examinations expose patients to risk without benefit and are a threat to the effective allocation of resources. There are many circumstances in which there is no indication for imaging at all. Simpson and Hartrick allude to this in their article with regard to chest CT scans, but overuse of imaging of the lumbar spine in acute back pain is another example. The wrong choice of test may lead to delay in diagnosis, hazards of the test itself and the risk of false-positive results. Reducing the inappropriate use of CT is especially important, as it is the predominant cause of the marked increase in population exposure to ionising radiation in recent years. Although there is a lack of consensus on the exact degree of risk posed by medical exposure to ionising radiation, the principles of radiation protection dictate that exposure be kept to the lowest level reasonably achievable. To reduce inappropriate use of diagnostic imaging, action is needed both by referring doctors and by providers of radiological services. Simpson and Hartrick have highlighted a specific situation relating to referral by GPs, but there are undoubtedly similar problems in hospital environments and in specialist practices. How can GPs improve their capacity to use imaging properly and effectively? Prohibiting referrals for CT by GPs would result in unacceptable stress on specialist services, long waiting times and, probably, increased costs. Restriction of CT requests to specific clinical indications would also most likely be impractical and open to interpretation. Picano3 has suggested a “radiological driving licence” for requesting doctors (with penalty points for inappropriate requests and licence withdrawal for repeated infringements) — a nice idea, but potentially difficult to administer. Education of referrers is surely the most practical solution. Imaging technology is becoming increasingly complex and expensive. Keeping abreast of the choices of modalities may be bewildering. GPs need to call on the consultative role of radiologists more frequently and effectively to ensure that the correct test and correct test protocol are used, to be made aware of the accuracy and limitations of the test, and (armed with an estimate of the pre-test probability of a disease) to better assess the significance of the result. Imaging guidelines based on evidence and expert consensus need to be disseminated, “marketed” and made easily accessible. Targeting the reduction of unnecessary tests in highly specific areas of general practice can be successful,5 but it is uncertain whether this approach is applicable over the wide range of imaging services and clinical scenarios. Simply mailing out information is inadequate6 and doesn’t guarantee accessibility or enable easy updating. The Royal Australian and New Zealand College of Radiologists (RANZCR), for example, has circulated its excellent booklet Imaging guidelines to GPs in the past, but the last edition appeared in 2001 (available on request at http://www.ranzcr.edu.au/contact/index.cfm). There is a need for guidelines in electronic format (such as the online publication Diagnostic Imaging Pathways, developed by the Western Australian Department of Health, http://www.imagingpathways.health.wa.gov.au), enabling continuous modification as new evidence appears,7 and these should preferably be integrated into other computerised systems already used by GPs. Hammett and Harris4 foresee the implementation of computerised order-entry systems providing guidance on test appropriateness, information on each test, and feedback on ordering patterns. Such guidelines would enable referrers to answer specific questions in relation to clinical scenarios and individual patients: Is imaging indicated? Will it change the diagnosis? Will it change the patient’s management? Will it do more harm than good? Am I asking for the appropriate imaging and in the correct order? Is there a non-ionising alternative to an x-ray-based examination?8 It behoves all clinicians to be aware of the approximate radiation dose and the attendant risk associated with the test they are requesting. Such knowledge is generally lacking.9 Radiologists, too, must take more responsibility for effective and appropriate use of imaging. The RANZCR, in its Quality Use of Diagnostic Imaging program,10 is facilitating this, but individual radiologists need to take action as well. GPs need education seminars on this topic. Radiologists have a duty to ensure that radiation exposure to individuals and communities is the lowest necessary. They have a consulting role that they have been guilty of ignoring and that referrers are guilty of underutilising. Radiologists need to act as gatekeepers, vet each request and provide feedback to the referrer if the request is inappropriate. This requires the referrer to provide adequate clinical details to ensure that the appropriate imaging protocol is used (eg, high-resolution chest CT for diagnosis and monitoring of diffuse interstitial lung disease with minimum radiation exposure versus higher dose helical chest CT for malignancy or pleural disease). When CT is required, radiologists (and radiographers) need to be reminded that modern CT scanners can employ techniques to reduce patient exposure. Low-dose and ultra-low-dose techniques (including CT,11 renal colic and CT colonography protocols) are often an option, but these require the active involvement and judgement of the radiologist. A marriage of knowledgeable and informative request writing, vigilant vetting of requests, and application of correct protocols will bring the enormous benefits of radiological imaging to the population in a safer manner.

Richard M Mendelson MRCP, FRCR, FRANZCR · Conor P J Murray MB BS, DCH, FRANZCR

A welcome alternative to the current cumbersome and inefficient system Australia’s system of ethical review of human research is based on a National Health and Medical Research Council (NHMRC) publication, the National statement on ethical conduct in research involving humans.1 This statement requires all research involving humans to be reviewed by an appropriately constituted human research ethics committee (HREC), whose primary role is to protect the welfare, rights and dignity of human research participants. It is also a requirement of Australian therapeutic goods legislation that all clinical trials that use unapproved therapeutic goods obtain approval from an HREC.2 There are currently 59 HRECs in New South Wales registered with the NHMRC, of which 23 are within the public health sector. Historically, HRECs were established by institutions or organisations to review research proposals conducted solely within their facilities, or involving only their researchers (single-site research). The ethical and scientific review of multicentre research, whereby a single research protocol is conducted at numerous sites, presents unique difficulties for HRECs, researchers, industry and governments.3-5 Under the current system, multicentre research projects are reviewed regularly by the HREC at each site where the research will be conducted, resulting in multiple reviews of the same project. As multicentre research grows, this process is becoming increasingly untenable. In 2005, the NSW Department of Health undertook a review of all research projects submitted to HRECs within the public health sector. In 2003, 148 multicentre research projects were reviewed 491 times, and in 2004, 196 projects were reviewed 607 times. It is clear that the current system has resulted in a number of inefficiencies, including the duplication of effort for HRECs and researchers, an increased burden on HRECs to provide reviews of adequate quality in a timely manner, and increased time from conception of a project to completion of recruitment of participants. In addition, the system is expensive to administer and hinders Australia’s international competitiveness in attracting quality research activities. Researchers, industry and HRECs have been calling for reform of the current system for many years.6,7 In response to these observations and after exhaustive consultation, at the end of 2006, the NSW Department of Health finalised a model for single ethical and scientific review of multicentre research, which will be implemented in July 2007. Further information can be found at: http://www.health.nsw.gov.au/healthethics/multicentre_research.html. The aim of the model is to provide for a single review of multicentre research projects within the NSW public health system, so that every research project is ethically and scientifically reviewed once only. There are three key points which underpin the model: the separation of research governance from the scientific and ethical review of a research project; the notion of a lead HREC; and the concept of a coordinating investigator. Research governance refers to the administrative aspects of research, including: support of department managers; the financial and human resources required to undertake the research project; and ensuring appropriate levels of insurance and indemnity. As many of these issues are site-specific, each site where the research is to be conducted will undertake their own site-specific assessment. A standardised six-page site-specific assessment form will need to be completed by the principal investigator at each site and assessed by a Research Governance Officer at the site. Lead HRECs will be accredited by the NSW Department of Health to conduct a single ethical and scientific review on behalf of all sites within the NSW public health system at which a research project is to be conducted. The actual process used by a lead HREC to undertake the ethical and scientific review remains the decision of each committee. The lead HREC will be responsible for overseeing the research project at all sites, including handling complaints from research participants. An HREC may be a lead HREC in relation to all types of research or in specific research areas only. These areas of research include clinical trials and interventional clinical research and general research including epidemiology, population health, health services, and qualitative and clinical research of a non-interventional nature. In line with the European Directive on the implementation of good clinical practice in the conduct of clinical trials on medical products for human use,8 lead HRECs should take no more than 60 days to reach a decision and communicate that decision to the coordinating investigator. The 60 days does not include time during which the HREC is awaiting a response from the investigator. Lead HRECs will retain the right to limit the number of applications reviewed at each meeting. However, as a number of lead HRECs will be accredited to conduct single ethical and scientific reviews, there will always be more than one lead HREC available to consider a multicentre research project. Under the new model, the research team will appoint a coordinating investigator. This person will be responsible for submitting the research project to the lead HREC. He or she will be able to choose the lead HREC to which to submit the ethics application, provided the HREC is accredited to review that area of research. Use of the NHMRC’s National Ethics Application Form (NEAF) will be mandatory for submission of all multicentre projects. While the site-specific assessment and lead HREC review may occur in parallel, the decision to authorise or not authorise the commencement of a research project at a particular site will only be made by the chief executive or delegate of the public health organisation when the lead HREC has granted approval and the site-specific assessment has been satisfactorily completed. This new model will be effective within NSW Health facilities only. Similar models to streamline ethical and scientific review by HRECs are being developed for the public health sector in Victoria and Queensland.9 The health departments in these states and in NSW have been cooperating to standardise the mechanisms that will be used in their various systems. This is in preparation for the introduction of a national system of single review, currently being examined by the NHMRC, and having been allocated $5.6 million in the 2007–08 federal budget.10 It is hoped that the new NSW model will achieve its goals of efficiency, effectiveness, timeliness, cost-effectiveness, reduction in workloads and transparency.

Helen E Fraser RN, BN, MPH · Ainsley E Martlew BMSc, MM · Deborah J Frew BA, LLB(Hons)

An update on the requirements of ICMJE’s clinical trial registration policy In 2005, the International Committee of Medical Journal Editors (ICMJE) initiated a policy requiring investigators to deposit information about trial design into an accepted clinical trials registry before the onset of patient enrolment.1 This policy aimed to ensure that information about the existence and design of clinically directive trials was publicly available, an ideal that leaders in evidence-based medicine have advocated for decades.2 The policy precipitated much angst among research investigators and sponsors, who feared that registration would be burdensome and would stifle competition. Yet, the response to this policy has been overwhelming. The ICMJE promised to re-evaluate the policy 2 years after implementation. Here, we summarise that re-evaluation, specifically commenting on registries that meet the policy requirements, the types of studies that require registration, and the registration of trial results. As is always the case, the ICMJE establishes policy only for the 12 member journals (a detailed description of the ICMJE and its purpose is available at http://www.icmje.org), but many other journals have adopted our initial trial registration recommendations, and we hope that they will also adopt the modifications discussed in this update. Key summary points In addition to accepting registration in any of the five existing registries, the International Committee of Medical Journal Editors (ICMJE) will accept registration of clinical trials in any of the primary registers that participate in the World Health Organization’s International Clinical Trials Registry Platform. Registration in a partner register only is insufficient. The ICMJE will begin to implement the WHO definition of clinical trials for all trials that begin enrolment on or after 1 July 2008. This definition states that a clinical trial is “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” The ICMJE will not consider results posted in the same clinical trials registry in which the initial registration resides to be previous publication if the results are presented in the form of a brief, structured (< 500 words) abstract or table. The research community has embraced trial registration. Before the ICMJE policy, ClinicalTrials.gov, the largest trial registry at the time, contained 13 153 trials; this number climbed to 22 714 one month after the policy went into effect.3 In April 2007, the registry contained over 40 000 trials, with more than 200 new trial registrations occurring weekly (D Zarin, Lister Hill National Center for Biomedical Communications, National Library of Medicine, National Institutes of Health, Bethesda, Md, USA, personal communication). The four other registries that meet the ICMJE criteria have also grown, as scores of journals have adopted the ICMJE clinical trials registration policy. In response to burgeoning registration, many investigators, sponsors, and government agencies have asked the ICMJE to recognise their local registries as databases that meet the policy requirements. Fortunately, the World Health Organization’s International Clinical Trials Registry Platform (ICTRP), which was nascent when the ICMJE began to require trial registration, has matured rapidly and provides options for those who desire a wider array of registries. The ICTRP has taken the first steps toward developing a network of primary and partner registers that meet WHO-specified criteria.4 Primary registers are WHO-selected registers managed by not-for-profit entities that will accept registrations for any interventional trials, delete duplicate entries from their own register, and provide data directly to the WHO. Partner registers, which will be more numerous, will include registers that submit data to primary registers but limit their own register to trials in a restricted area (such as a specific disease, company, academic institution, or geographic region). The ICMJE strongly supports the WHO’s efforts, through the ICTRP, to develop a coordinated process for identifying, gathering, de-duplicating, and searching trials from registries around the world, thus eventually providing a one-stop search portal for those seeking information about clinical trials. In addition to the five existing registries, the ICMJE will now also accept registration in any of the primary registers that participate in the WHO ICTRP. Because it is critical that trial registries are independent of for-profit interests, the ICMJE policy requires registration in a WHO primary register rather than solely in a partner register, since for-profit entities manage some partner registers. As previously, trial registration with missing or uninformative fields for the minimum data elements is inadequate.1 Initially, the ICMJE required registration of all clinically directive trials, which it defined as “any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome”.1 In May 2005, the ICMJE clarified this definition to exclude preliminary trials designed to study pharmacokinetics or major unknown toxicity (phase I trials).5 However, the ICMJE recognises the potential benefit of having information about preliminary trials in the public domain, because these studies can guide future research or signal safety concerns. Consequently, the ICMJE is expanding the definition of the types of trials that must be registered to include these preliminary trials and adopts the WHO’s definition of a clinical trial: “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes”.4 Health-related interventions include any intervention used to modify a biomedical or health-related outcome (eg, drugs, surgical procedures, devices, behavioural treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. As previously, purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. The ICMJE member journals will start to implement the expanded definition of clinically directive trials for all trials that begin enrolment on or after 1 July 2008. Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal. Over the time during which registration of trial methods has become common practice, several forces have begun advocating for registration of trial results. We recognise that the climate for results registration will probably change dramatically and unpredictably over coming years. For the present, the ICMJE will not consider results posted in the same primary clinical trials register in which the initial registration resides as previous publication if the results are presented in the form of a brief, structured (< 500 words) abstract or table. The ICMJE favours a standard abstract format for results reporting, and the CONSORT (Consolidated Standards of Reporting Trials) group’s forthcoming guidelines for abstracts related to trials may be one such option. The ICMJE believes that parties interested in results registration should consider requiring the deposition of such an abstract in the registry 24 months after closure of data collection if results are not published in a peer-reviewed venue by that time. The registered abstract should either cite any related full, peer-reviewed publications or include a statement that indicates that the report has not yet been published in a peer-reviewed journal. Researchers should be aware that editors may consider more detailed deposition of trial results in publicly available registries to be prior publication. When submitting a paper, authors should fully disclose to editors all posting in registries of results of the same or closely related work. Three years ago, trial registration was the exception; now it is the rule. Registration facilitates the dissemination of information among clinicians, researchers, and patients, and it helps to assure trial participants that the information that accrues as a result of their altruism will become part of the public record. The WHO’s global efforts towards comprehensive trials registration and the ICMJE’s requirements for registration aim to increase public trust in medical science.

Christine Laine MD, MPH, Senior Deputy Editor · Richard Horton FMedSci, Editor · Catherine De Angelis MD, MPH · Jeffrey M Drazen MD · Frank A Frizelle MB ChB, MMedSc · Fiona Godlee MB BChir, BSc · Charlotte Haug MD, PhD, MSc · Paul C Hébert MD · Sheldon Kotzin MLS · Ana Marusic MD, PhD · Peush Sahni MD, PhD · Torben V Schroeder MD, DMSc · Harold C Sox MD · Martin B Van Der Weyden MD · Freek W A Verheugt MD

Outcomes for patients must be a core variable in this complex research The report by Oldmeadow and colleagues (→ Experienced physiotherapists as gatekeepers to hospital orthopaedic outpatient care) in this issue of the Journal details an evaluation of assessment by physiotherapists as an alternative to orthopaedic surgeon management of patients referred by general practitioners for musculoskeletal conditions.1 The authors describe a service funded by the “Better Skills, Best Care” initiative of the Victorian Department of Human Services, whereby two highly qualified physiotherapists screened patients with uncomplicated conditions before parallel assessment by a surgeon. Their conclusions were that the service was beneficial (reduced waiting lists), acceptable (with good levels of satisfaction among all stakeholders) and of high quality (most physiotherapist management decisions were in accord with those of the surgeon). Oldmeadow and colleagues directly address a topic of real importance, as highlighted by the July 2006 issue of the Journal, devoted to task transfer.2 Their findings support what is happening in other countries, particularly the United Kingdom, where the practice of substituting physiotherapists and other allied health professionals (AHPs) for medical personnel has increased over the past 5 years. These changes are taking place largely in response to: increased waiting lists; shortage of medical staff in specific disciplines; AHP aspirations; and, indeed, politics, with efforts to modernise the National Health Service.3 A number of studies have now shown that nurses,4 AHPs,5 and staff specifically trained as physician assistants6 can take on a number of tasks and roles usually performed by doctors. Perhaps the fact that different health care staff are clearly able to learn and apply new skills and techniques should no longer be surprising. While welcoming evaluation of new approaches to care when translated from one environment to another, this report and other research about new roles prompts some key questions, including: Are the right people with musculoskeletal pain on tertiary care waiting lists? When is the physiotherapist the best person to see patients with musculoskeletal pain? Does “impact” mean the same thing in workforce research as it does in other clinical research? As waiting lists for hospital treatment in most countries grow, it is paramount to find the best ways of minimising the number getting onto those lists in the first place. Speedy exit from the list certainly reduces waiting lists, and increased resource allocation to tertiary services currently seems a central strategy, with reports of waiting list difficulties being rare in countries with comparatively greater expenditure on health.7 Without additional resource allocation into health, it would seem sensible to maximise referral of those who have potential to gain from surgical opinion (ie, appropriate targeting) and minimise referral of those who actually have little to gain. It has been noted that in the management by GPs of hip and knee pain in over 300 000 British patients over the age of 65, only 2% were referred to physiotherapy at the initial consultations, increasing to 11% if the patients had been seen again within 12 months, and to 17% if they were seen again within 36 months.8 As the patients in this study had a high proportion of degenerative joint disease, they would arguably benefit from highly skilled physiotherapy rather than referral for orthopaedic assessment, given that physiotherapy has been shown to be effective at reducing pain and medication use9-11 and improving function10,12 in patients with degenerative joint disease of the knee. In many developed countries, clinical guidelines have been developed to guide GPs and other health professionals as to when referral to an orthopaedic surgeon is required and appropriate.13,14 Given the high numbers of people on waiting lists, maybe more needs to be done to increase the usability and use of, and reward for using, such guidelines. There must also be some surety of access to physiotherapy, in view of warnings about a serious shortage of therapists by the Australian Physiotherapy Association.15 If the whole workforce system is not considered, we may simply find excessive waiting lists for surgical review are replaced by excessive waiting lists for physiotherapists. At the heart of any question about patient management should be: “What is the best treatment for this particular patient at this point in time?” If we forget this, we may actually fail to use and develop our workforce in the most effective and cost-efficient way. While having very experienced physiotherapists working as “consultant” practitioners makes sense, is having them predominantly perform duties as an alternative to consultant physicians or surgeons the best approach? While Oldmeadow et al restricted their sample to uncomplicated musculoskeletal pain, and excluded patients with psychosocial issues that contribute to symptom chronicity, we suggest that those with psychosocial issues may be one of the very groups who could benefit most from an enhanced physiotherapy intervention. The enhanced scope here would go beyond advanced skills in assessing joint impairment and function. Rather, the physical and technical skills would be augmented by the knowledge, ability and confidence to consider the psychosocial factors that frequently perpetuate painful conditions and lead to enduring disability. A novel intervention was recently described, in which AHPs (including physiotherapists) were trained to deliver a brief psychosocial intervention to complement the usual scope of physical therapy in patients with musculoskeletal pain.16 While this sample was different from that in the report by Oldmeadow et al (the patients were not on waiting lists for surgery, having either had surgery, or having been assessed as not requiring surgery), the rate of return to work for those with the expanded scope treatment was 25% better than for those with usual physical therapy alone. This indicates a different motivation for, and approach to, task substitution or role replacement, and one that seems to achieve good outcomes for patients. Oldmeadow et al aimed to evaluate the “impact, quality and acceptability” of the intervention and concluded that physiotherapists were competent and safe in this intervention. While it certainly appears that all the stakeholders involved found the service acceptable (with the caveat that satisfaction is a particularly tricky area to measure well), evidence about impact, quality, safety and competence are complex, and may require more complex methods of assessment to be persuasive. Shorter waiting lists are indeed one effect of an intervention, but without knowing eventual outcomes for patients, that effect may be of dubious relevance. If the dominant approach to evaluation in task substitution/enhancement research remains predominantly to do with output (such as waiting list reduction), we will really have little idea of which approach to the development of new roles is most likely to be beneficial. We agree with Oldmeadow et al that more research into new roles is required. Definitive answers to important questions are needed, and it is important that the complexity involved in this type of research is not overlooked.17 In particular, patient health outcomes must be a core variable in that mix of complexity if we are to make persuasive statements about impact, quality, safety and competence.

Kathryn M McPherson PhD · Duncan A Reid MHSc(Hons), PgDipHSc, DipPhys

Diagnostic imaging is a key component of patient management and must be provided in a clinical context Task transfer has been suggested as a solution to medical manpower shortages in this issue of the Journal1 and elsewhere.2-4 The Royal Australian and New Zealand College of Radiologists (RANZCR) has recently explored this issue pertaining to diagnostic imaging (DI)5 in response to the Quality Use of Diagnostic Imaging (QUDI) Program’s discussion paper on role evolution. Radiologist workloads are heavy and increasing.6 In addition to the general growth of medical services, traditional history taking and clinical examination are increasingly supplemented by and dependent on multiple and more complex DI to provide a definitive diagnosis. Expansion of DI is placing workforce pressures on all members of the DI team. Radiographers are also in short supply. Radiology services have always been provided by a multidisciplinary team, including radiologists and radiographers. The optimal DI outcome is dependent on team members working in a cooperative manner, mutually recognising and maximising individual areas of expertise. Rapid changes in DI technology necessitate constant review of work practices to provide the most efficient service. Optimal patient outcome must form the cornerstone of any changed practice. Role evolution, including task substitution and delegation, is one potential means of better utilising the skills of the whole DI team. It must be considered in the context of responsibilities and core competencies to perform tasks. Clear definition of all DI tasks and essential task competencies is thus essential. The radiologist carries a duty of care and legal responsibility to the patient and referring doctor for the overall conduct and result of the radiology service. The radiologist’s expertise is built on a background of medical training and experience followed by specialist training in medical imaging. The comprehensive radiology service is an integral component of patient management. It includes appropriate use, performance and interpretation of DI and imaging-guided intervention, drawing on the specialist skills and knowledge of the radiologist. The radiology report, which requires technical observations and medical interpretation in the clinical context, documents the medical specialist service. Such a report can only be provided by a radiologist. Focusing on image reporting by non-medical personnel assumes that preclinical, clinical and specialist training and experience can be fast-tracked or avoided without negative impact on the nature and quality of the DI service. In addition, radiology has become a more body-system-based rather than modality-based service — reflecting patient presentation and radiology’s increasingly clinical role. Plain x-rays are just one component of the often complex and integrated imaging required to optimise patient management. There is also a misconception that plain x-ray interpretation is simple and thus readily delegated, and that the radiologist’s role is limited to provision of images and reports. This ignores the clinical context of the DI service. The RANZCR is constantly considering entire service delivery measures to mitigate the impact of DI team workforce shortages. Providing additional training places may eventually ease the burden on DI teams, but there will be a considerable lag period. There is little doubt that a substantial proportion of current imaging has no impact on patient outcomes and is thus unnecessary. Increased early involvement of the radiologist in clinical management, particularly to advise appropriate imaging, would minimise unnecessary studies. This would relieve workforce pressures across the entire DI team, whereas reporting by radiographers would exacerbate current radiographer shortages and potentially diminish the clinical value of the DI service. Quality and efficiency of service to patients is paramount, and system changes should not be driven primarily by the desire to create potential new career paths, although the RANZCR recognises that work satisfaction of all DI team members should always be considered. Introducing new technologies such as picture archiving and communication systems (PACS) will largely eliminate the need for film production by radiographers and handling by radiologists, thus contributing significantly to workforce efficiency. In summary, the RANZCR recognises that coping with increasing demands on DI services requires innovative approaches. The cooperative team approach remains crucial to service delivery. Scope for review of tasks within the team may exist, but any changes must occur with current key competencies maintained. The radiologist’s responsibility for the totality of the DI service is a function of core skills and experience and is non-delegable. Radiologists are uniquely placed to advise the need for and choice of imaging. They supervise and interpret radiological and interventional procedures and communicate results to referring clinicians. Any system redesign must build on these pivotal roles of the radiologist. The RANZCR is firmly of the view that the radiology report, which communicates the medical interpretation of the patient’s imaging in a clinical context, cannot be currently delegated to those who are not trained initially as medical practitioners and then as medical imaging specialists.

Lizbeth M Kenny MB BS, DRACR, FRACR · Matthew W Andrews MB BS(Hons), MMed, FRANZCR

Despite advances in treatment, the greatest gains in cancer control are achieved through prevention The translation of basic cancer research on cell growth to the clinic has resulted in a paradigm shift in cancer treatment by providing new therapeutic targets. The initial successes — the monoclonal antibodies trastuzumab and rituximab — have improved the survival of patients with breast cancer and lymphoma, as has the small molecule imatinib mesylate in chronic myeloid leukaemia; all have less toxicity than conventional cytotoxics.1 The challenge is to fund these new high-cost drugs. Although targeted drugs can be limited to the specific patient populations expressing the appropriate target, further funding is then required to screen patients for those targets. New models of cost- and risk-sharing between governments and industry must evolve to pay for these developments. A similar evolution in the diagnosis of cancer will see genomics and proteomics become a more important guide to treatment selection and prognosis than traditional pathology tests.2,3 These research technologies will need to be developed in such a way that they can provide guidance to clinicians as quickly as conventional techniques, and will also require upskilling of current clinicians, pathologists and their trainees. Investment in cancer research pays considerable dividends.4 There is a need for more funding of translational research — it has been an ongoing concern that Australia lacks the infrastructure to take promising new drug discoveries all the way from the laboratory into clinical practice. Newer fields, such as health services research, with its potential to address the pressing issue of inequities in access to treatment and cancer outcomes in rural and remote Australia, and psychosocial research, require new sources of funding. The challenge in Australia is to make research less fragmented and better targeted to questions of international importance, which we have the capability to competitively pursue. Although breakthroughs in cancer treatment generate significant media coverage, the greatest gains in cancer control in Australia are to be made in prevention strategies based on established science. Evidence-based health promotion campaigns have provided strong economic returns, yet governments invest only 1.7% of the overall health care budget in primary prevention.5 More than 21% of cancer deaths in Australia are attributed to tobacco use. Add smoking to excessive sun exposure, inadequate fruit and vegetable intake, alcohol, inactivity and obesity, and more than 34% of cancer deaths in Australia can be attributed to modifiable behaviour.6 Currently, 17.4% of Australians smoke.7 Australia has a smoking prevalence among the world’s lowest, but from a public health perspective it remains unacceptable that almost one in five Australians incurs a significant yet avoidable cancer risk by continuing to smoke. The prohibition of broadcast tobacco advertising in the mid 1970s was the first key policy step in a series of tobacco control reforms that have since been shown to have saved 17 000 Australians from premature death.8 This government initiative required no taxpayer funding, but a cultural shift. Where funds have been invested, the returns have been enormous, with the $176 million spent on antismoking campaigns over the past 30 years delivering $8.6 billion in benefits.9 There remains no more effective cancer control measure than reducing smoking, but there is a risk that the incremental reduction in smoking prevalence achieved over the past 30 years will stall unless the tobacco control effort is sustained. Smoking also contributes significantly to social inequities in health outcomes. For example, a smoking prevalence of 50% among Indigenous Australians10 is believed to be a major cause of the significantly poorer cancer survival rates among Aboriginal and Torres Strait Islander peoples. Targeted approaches are needed to break the cycle of social disadvantage, smoking, and cancer evident in specific population groups. Moreover, studies on tobacco control achievements over recent decades strongly suggest that a more sustained, whole-of-government commitment, built around integrated policy, social marketing, and research, could bring smoking prevalence down in Australia by a further 1% annually. Estimates based on recent trends indicate that reducing smoking prevalence by 5% in 5 years would save more than $1.15 billion in health care costs over the next 30 years.8 Yet some major political parties continue to accept donations from tobacco companies,11 and governments delay legislation to ban smoking in enclosed public spaces, and invest taxpayer funds in tobacco companies on the basis of sound economic management — despite having to spend more taxpayer funds on treating tobacco-related diseases (at least until patients die of them). While public policy has been gradually reducing the tobacco burden, obesity is escalating as a community health crisis. Obesity is linked to colorectal cancer, postmenopausal breast cancer, and kidney, oesophageal, gall bladder and endometrial cancers.12 Obesity control includes encouraging and facilitating physical activity and communicating dietary advice. The tobacco experience suggests that restricting junk-food advertising to children is likely to have an important impact, as supported by early Canadian data.13 This measure is not about restricting choice, as well targeted multimillion-dollar advertising campaigns already create an imbalance in the choices that uninformed and often disadvantaged families see as being available to them. Other lifestyle messages require more subtle public education. Advice from the SunSmart skin cancer prevention program must balance the need to avoid excessive sun exposure with the importance of low-level sunlight for vitamin D production. Similarly, while any alcohol consumption carries some cancer risk, the more you drink, the higher the risk — a factor that should be balanced against the benefits of very low alcohol intake in preventing cardiovascular disease. Cancer screening is another area that is presenting new opportunities and challenges. The benefits of breast cancer screening need to be continually reinforced to ensure high participation rates by eligible women. A new challenge for cervical cancer screening is ensuring continued high participation despite the introduction of the human papillomavirus immunisation program. The new National Bowel Cancer Screening Program requires community and professional education, a patient registry to ensure follow-up, and extra resources and minimum standards to meet increased colonoscopy demand. This will test the shared responsibilities for health care between national and state/territory governments — a potential barrier to efficient health policy implementation. The community must also understand that an ineffective screening test — one that evidence shows lacks the specificity and sensitivity to reduce cancer mortality on a population basis — is worse than no test at all, as the false positives and negatives can lead to poorer health outcomes than would surveillance on a case-by-case basis. The key is ensuring that evidence guides the implementation of government-funded measures aimed at cancer prevention and early detection — at a time when we could prevent well over a third of all cancer deaths in Australia using existing prevention and early detection technology. By investing more taxpayer funds in the high proven returns of cancer prevention and early detection, we could make resources available to better support the significantly increasing numbers of new cancer patients associated with population ageing over the coming years. Savings generated through improved prevention could also fund targeted cancer research to help further reduce the impact of cancer in the future. Increasing the cancer workforce, and improving workforce training and support through a more integrated approach across jurisdictions, is also pivotal to ensuring we can provide optimal multidisciplinary cancer care to meet the challenges of the future.

Ian N Olver MD, PhD, FRACP

High rates of this disease are the face of Indigenous disadvantage While acute rheumatic fever (ARF) has become a rare curiosity in Australia’s non-Indigenous population, its incidence in Indigenous Australians living in remote areas remains among the highest reported in the world. It is unlikely that such a stark contrast between two populations living within the same national borders exists for any other disease or on any other continent. The new evidence-based review and guideline for diagnosis and management of ARF and rheumatic heart disease (RHD) is an important tool for clinicians who care for Indigenous Australians (→ An Australian guideline for rheumatic fever and rheumatic heart disease: an abridged outline).1 But the guideline also prescribes a clear course of action for health policymakers. It makes a compelling case for focusing on the provision of secondary prophylaxis via coordinated, register-based RHD control programs that have guaranteed long-term funding. At the minimum, programs are needed in the Top End of the Northern Territory, Central Australia (including areas of South Australia and Western Australia near the NT border), northern WA, and northern Queensland. Other jurisdictions may also require control programs, but further disease burden data are needed to establish this. It is critically important to ensure that people with ARF and RHD receive good treatment and preventive care. But let’s not lose sight of the main game. Treatment of ARF and RHD, and secondary prevention-based control programs, are bandaid solutions to an underlying tragedy. ARF and RHD are classic diseases of social injustice. The past 50 years have witnessed dramatic declines in the prevalence of ARF and RHD throughout the industrialised world, resulting mainly from improvements in living conditions, socioeconomic conditions, sanitation and medical care, and from reduction in household crowding.2 Unfortunately these improvements are yet to be seen among a number of populations defined by socioeconomic status, ethnicity or geographical location.3 In essence, ARF and RHD are not only diseases exclusively borne by the disadvantaged, but also key indicators of disadvantage itself. In remote Australian Indigenous populations, the effects of disadvantage are so entrenched that it is likely to take several generations, and steadfast political will, before they are overcome. Rates of death from RHD among Aboriginal people in the Top End of the NT exceed those reported in many industrialised countries over a century ago.4 There is little or no evidence of improvement over at least the past three decades.5 As a consequence, Indigenous Australians continue to die before their time from a highly preventable, highly treatable and completely avoidable illness.4 Ongoing disparities in the burden of ARF and RHD reflect a number of failures in the development and delivery of health and health-related services. Failure to provide secondary prophylaxis can be due to missed diagnoses, poor continuity of care, a lack of trust and communication between patients and care providers, high staff turnover, a lack of appropriate health education, and, perhaps most importantly, a lack of political and bureaucratic commitment to solving the problem. Failure in primary prevention of ARF and RHD (ie, in preventing the acquisition of group A streptococcal infections) reflects the failure to provide Indigenous communities with the appropriate type and level of housing and environmental conditions that all Australians should expect. The federal government has targeted a 50% reduction in death due to RHD by 2008.6 While this is an unrealistic expectation, significant achievements are possible within the short to medium term, as has been witnessed with comprehensive approaches to control of ARF and RHD in the French Caribbean7 and with the establishment of register-based ARF/RHD control programs across New Zealand.8 Perhaps the most frustrating thing is that preventing premature death due to RHD is more achievable than solving an ever expanding list of other health and social problems facing Indigenous Australians. To prevent premature death due to RHD, a number of concrete steps must be taken. Firstly, we must commit to alleviating the underlying socioeconomic determinants of ARF and RHD. The most important of these determinants — overcrowded housing — is also the easiest to address, but requires a dramatically greater investment by governments than we are currently seeing. A recent study confirmed the extreme levels of household crowding experienced in many remote communities:9 in two large NT Aboriginal communities, the median number of people per house was 17 and 14, respectively, with a median of 6.9 and 7.5 people per bedroom, respectively. Secondly, we must ensure that each person with a history of ARF or RHD receives appropriate care. This entirely achievable goal would prevent Aboriginal children dying unnecessarily from this disease. Thirdly, we must ensure that political will delivers the deliverable and prevents the preventable. As long as modern Australia continues to accept the large and growing health and social disparities experienced by its Indigenous people, it fails in its duty to protect and provide for the most vulnerable. Will we be brought to account for our failure to deal with these disparities, or will cries for justice be silenced, as has happened with so much of the history of Australia’s first people?

Alex Brown BMed, MPH, FCSANZ · Malcolm I McDonald FRACP · Tom Calma

A united stand from medical professionals and organisations will send a powerful message May 2007 is the 40th anniversary of the 1967 Referendum, when an overwhelming majority of the Australian population voted to end discrimination against Aboriginal and Torres Strait Islander peoples.1 While some gains have been made since 1967,2 inequalities in health status between Aboriginal and non-Aboriginal Australians remain. In the Medical Journal of Australia alone, medical and health professionals have contributed to over 150 articles about Aboriginal and Torres Strait Islander health in the past 6 years. All levels of government have set out frameworks, strategies and recommendations to improve the health of Indigenous Australians, and have celebrated their commitments.3 Aboriginal and Torres Strait Islander leaders and representative organisations have supported exemplary health programs and shared these success stories in the hope of having their capacity enhanced to better provide for their community’s health needs.4-6 The research has been done,7 so why are governments not acting on their own recommendations? Since the release of the Aboriginal and Torres Strait Islander Social Justice Report 2005,8 leading Indigenous and non-Indigenous medical and health organisations and human rights groups have been asking this question. This momentum led to an open letter published in The Australian newspaper in December 2006,9 and the beginning of a campaign calling on all Australian governments and the public to “commit to a plan of action to achieve health equality for Indigenous peoples within twenty-five years.” The letter was signed by 37 key health and human rights agencies, and more agencies are signing up to the campaign daily. The purpose of the open letter (reproduced in the Box) is to campaign for a national commitment to achieving health equality for Aboriginal and Torres Strait Islanders by tackling areas where there is insufficient action, and where evidence indicates that action will deliver substantial gains. This approach is laid out in the Social Justice Report 2005.8 The open letter: sets a target of achieving health equality within a generation (25 years), thereby challenging incremental policy approaches that have avoided benchmarks, timeframes, comprehensive measures and accountability; directs attention to the evidence-based priority areas; is led by strong, united Aboriginal and Torres Strait Islander health organisations and an Indigenous workforce providing cultural and professional leadership, challenging views that Indigenous Australians are not taking responsibility; and is supported by a significant and increasing number of powerful Australian health and human rights groups. The open letter states that “Indigenous Australians continue to needlessly suffer and die early, not from a lack of solutions or government commitments, but from a lack of political will and action.” How can the Australian medical community assist? First, they must ask themselves if they are prepared to remain complicit in the real lack of will and action shown by Australian governments at all levels. Australia’s shameful record in incremental (and hence ineffectual) actions to redress health disparities between Aboriginal and non-Aboriginal Australians reflects particularly poorly on medical and health professionals. Is it acceptable that international governments have made significant advances in the health of their indigenous peoples while ours lags behind?10,11 Are we happy to keep writing the reports and advocating for resources only to have those efforts fail? (For every dollar spent per person on health goods and services for non-Indigenous people in the 2001–02 financial year, only 18 cents more per person was spent on Indigenous peoples, despite their health status being three times poorer.12) The interest of this Journal’s readership on this matter, and our professional organisations’ policies indicates we are not. Second, as distinguished and respected people in prominent positions in society, medical and health professionals must not underestimate their ability, and indeed their responsibility, to advocate for health equity. If the missing ingredient is a lack of political will, perhaps the medical profession can shift that will and public opinion. Unity on this matter as a profession and an organised course of action sends a powerful message that we are both willing and able to make the health of Aboriginal and Torres Strait Islander peoples a top health priority. Many important public health and humanitarian gains have been made through targeted campaigning. A good example is the recent mental health campaign, led by “beyondblue”, which resulted in an announcement of $1.8 billion in new funds in the 2006 budget.13 As leading advocates for the health of Aboriginal and Torres Strait Islander peoples, we are humbled and honoured to be working with many committed and skilled colleagues — both Indigenous and non-Indigenous. We know many of these colleagues share our frustrations at the funding shortfalls preventing the delivery of adequate health care to Aboriginal and Torres Strait Islander peoples.7 We now appeal to the Australian medical community to support us. Here we present the open letter again to coincide with the 1967 Referendum celebrations, inviting you to come on board. Speak or write to your federal and local politicians. To be a party to the open letter and the Indigenous health campaign, send your support, your signatures and your logo to sjreportAThumanrights.gov.au. Nothing will send a more powerful message than every medical and health organisation in this country joining together in a campaign for health equality for our nation’s first peoples. Open letter calling for equity in Indigenous health Signed by: National Aboriginal Community Controlled Health Organisation, Human Rights and Equal Opportunity Commission, Congress of Aboriginal & Torres Strait Islander Nurses, Aboriginal Medical Services Alliance Northern Territory, Australian Indigenous Doctors’ Association, and 32 other health and human rights agencies. Full list and further information available at: http://www.humanrights.gov.au/social_justice/health/health_OpenLetter.html

Mark Wenitong BMed · Romlie Mokak BSocSci, GradDipSpecEdu · Henry Councillor · Dea Delaney Thiele PostGradDipHealthManage · Tom Calma

Molecular genetics can facilitate a successful switch to oral diabetes therapy The increase in type 1 and type 2 diabetes in childhood has been well documented worldwide and in Australia.1,2 In addition, the separate entity of monogenic diabetes is increasingly recognised in paediatric diabetes, and now encompasses neonatal diabetes mellitus and maturity onset diabetes of the young (MODY)3 (Box 1). Monogenic diabetes is defined as diabetes caused by a single gene defect. A diagnosis of monogenic diabetes should be considered in a child who is diabetes-associated-autoantibody negative, is diagnosed with diabetes in the first 6 months of life, has a parent with diabetes, and/or is not markedly obese. Although uncommon — its frequency is estimated to be 1%–3% of all childhood diabetes3 — the clinical relevance of this condition is that at least some of those affected (in particular, those with MODY1 and MODY3) can achieve very good diabetes control with sulfonylurea rather than insulin therapy. Neonatal diabetes mellitus presents in the first 6 months of life with signs of hyperglycaemia — polyuria, dehydration, failure to thrive and, in many, frank diabetic ketoacidosis. Diabetic ketoacidosis is an important diagnosis to consider in an infant who presents critically unwell because the clinical picture may mimic sepsis. While the reported incidence of neonatal diabetes mellitus is one in 500 000 newborns,4 the estimated incidence is thought to be a lot higher, and it may be the cause of some unexplained infant deaths. About half of affected patients will have transient neonatal diabetes mellitus, where insulin treatment can be discontinued within a median of 3 months (although diabetes mellitus may recur in the second or third decade of life). In contrast, patients with permanent neonatal diabetes mellitus have, until recently, required insulin therapy for life. The revolution in patient management we describe here is due to molecular genetic analysis of the ATP-sensitive potassium (KATP) channel of the pancreatic beta cell (Box 2). Sulfonylureas have traditionally been used to treat type 2 diabetes mellitus. They act by binding the sulfonylurea receptor (SUR1), which closes KATP channels, thereby stimulating endogenous insulin production from the pancreatic beta cell. Gloyn et al demonstrated that some patients with Kir6.2 potassium channel activating mutations secreted insulin in response to the intravenous sulfonylurea tolbutamide.5 Subsequently, the Neonatal Diabetes International Collaborative Group conducted a trial of glibenclamide, an oral sulfonylurea, in 49 patients with Kir6.2 mutations. This trial included two Australian centres, with three children — one white and two of Middle Eastern ethnicity. An impressive 90% of the trial patients were successfully switched from insulin to glibenclamide.8 Importantly, the responsiveness in vitro of mutant ATP channels to tolbutamide was proportionate to the patient’s response to glibenclamide. This enables a degree of predictability of whether a patient is likely to successfully switch from insulin to oral therapy. Not only was oral therapy welcomed by families of patients, but the switch from insulin resulted in significant improvement of metabolic control, with glycated haemoglobin levels dropping from 8.1% to 6.4% after 12 weeks of treatment.8 Insulin response to oral glucose load was increased in those tested. Continuous glucose monitoring has also shown fewer fluctuations in postprandial glucose,9 which families report improves the child’s general wellbeing. However, the story is not all rosy — some patients with Kir6.2 activating mutations known to have poor in-vitro response to tolbutamide may not be able to switch to oral therapy. It is therefore important to determine the exact genetic mutation involved, so that families can be counselled about the chances of a successful switch. In our experience, such counselling was helpful in lessening the disappointment when a 7-year-old girl with a Kir6.2 mutation, who had presented with ketoacidosis at 7 months of age, remained insulin-dependent despite maximal glibenclamide dose. The diagnosis of neonatal diabetes mellitus should be considered in any critically ill infant, and the International Society for Pediatric and Adolescent Diabetes recommends that all infants who develop diabetes mellitus in the first 6 months of life be tested for a genetic mutation in the KATP channel.10 DNA from peripheral blood can be sent to a diabetes research laboratory in Exeter in the United Kingdom for testing (see http://www.diabetesgenes.org). To date, 20 Australian children, who had been insulin-dependent from less than 6 months of age, have been genotyped. Seven tested positive for mutations in Kir6.2 and three for mutations in SUR1 (Professor Andrew Hattersley, Peninsula Medical School, Exeter, UK, personal communication), and some have gained insulin independence. While molecular genetics can now help classify and facilitate management of childhood diabetes, regardless of the type of diabetes (type 1, type 2, or monogenic), all children who present with severe fasting hyperglycaemia and ketoacidosis will initially require insulin therapy to reverse the metabolic abnormalities. 1 Classification of primary diabetes mellitus in children Type 1 diabetes is characterised by the presence of diabetes-associated autoantibodies (islet cell, insulin, glutamic acid decarboxylase, and tyrosine phosphatase). A number of children with type 1 diabetes may be obese at diagnosis. Type 2 diabetes is characterised by obesity, negative antibodies and raised C-peptide levels. It is more common in non-white people than type 1 diabetes. Comorbid obesity can make the distinction between these two types of diabetes difficult. Monogenic diabetes is caused by a single gene abnormality. Maturity onset diabetes of the young (MODY) 1 and MODY3 are due to transcription factor mutations. Children with monogenic diabetes are not generally obese. Some children with monogenic diabetes present in the neonatal period with ketoacidosis. 2 Subunit structure of the ATP-sensitive potassium (KATP) channel of the pancreatic beta cell* The KATP channel consists of four sulfonylurea receptor (SUR1) subunits and four potassium channel (Kir6.2) subunits. Closure of the KATP channel is required for glucose-stimulated insulin secretion from the pancreatic beta cell. Conversely, opening of the KATP channel inhibits insulin secretion. Inactivating mutations of genes encoding both SUR1 (ABCC8) and Kir6.2 (KCNJ11) subunits keep the channel closed and are known to cause uncontrolled insulin secretion, resulting in congenital hyperinsulinism. It was hypothesised that activating mutations of these genes would keep the KATP channel open and cause permanent neonatal diabetes mellitus (PNDM). In 2004, Gloyn et al reported six novel heterozygous mutations in 10 of 29 patients with PNDM, including a 5-year-old Sydney girl who had been treated with insulin from 6 weeks of age.5 Subsequently, Proks et al reported a patient with activating mutations of ABCC8,6 and Babenko et al reported ABCC8 mutations in two of 29 patients with PNDM and seven of 44 patients with transient neonatal diabetes mellitus.7 KATP channels are also found in skeletal muscle and neurones throughout the brain, and some patients with Kir6.2 activating mutations have extrapancreatic features — motor skill and language delay, muscle contractures, epilepsy, and dysmorphic features — leading to the description of a new syndrome, known as DEND (Developmental delay, Epilepsy, Neonatal Diabetes) syndrome. In-vitro studies of mutant KATP channels have shown a correlation between the degree of KATP channel insensitivity and severity of the clinical phenotype.5 * Adapted from: Sperling MA. ATP-sensitive potassium channels — neonatal diabetes mellitus and beyond [editorial]. N Engl J Med 2006; 355: 507-510. PIP2 = phosphatidyl-inositol-4,5-bisphosphate.

Shubha Srinivasan MB BS, MRCP, FRACP · Kim C Donaghue MB BS, PhD, FRACP

A wholly state-funded or federally funded system of health care, concentrating on providing integrated services, might circumvent the political blame game During 2005 and 2006, the bipartisan House of Representatives Standing Committee on Health and Ageing conducted a nationwide inquiry into how the Australian Government could take a leading role in improving delivery of highest quality health care to all Australians.1 This inquiry received 159 submissions and conducted hearings and interviews in each Australian state and territory. The fractured relations among the state, territory and federal governments that surface when the bills for health care roll in motivated the Committee’s choice of title for its report — “The Blame Game”. The Blame Game describes conflict in the division of roles and responsibilities between federal and state governments, and the disconnection between public and private health systems, defining these factors as causes of impaired economic efficiency (which they are), but without linking them to the changing nature and extent of disease in Australia. Like atheromatous plaques tolerated for years, blame-game policies are now stenosing, blocking effective financial channels for health services to flow to those with chronic health problems. The growing pressure for care of patients with chronic illness makes resolving the blame-gaming of health service financing more urgent than if it were a matter of financial inefficiency alone. Of course, all health services — acute and chronic — would benefit from abolition of the blame game, but financing care for people with chronic illness should be rearranged as a working example of care across all providers funded from one source. This could reduce the transaction costs that proved problematic with the Australian coordinated care trials.2 Three actions now might prevent an infarct in our ability to provide health care in the future. National agendaFirst, we need a national agenda for the future of health care in Australia. This could start from the principal recommendation of The Blame Game: a national health agenda focused on financing health care. However, the agenda should reverse the usual priorities and begin from a concern for health, and only then consider financing arrangements. This would be a splendid prelude to negotiating the next Australian Health Care Agreements (AHCAs) in 2008. An agenda headed by the prevention and management of chronic illness could draw on the National Chronic Disease Strategy (NCDS).3 The NCDS identified the scope of the problem — chronic illness accounts for 80% of the burden of disease (including mental illness and injury) and for some 70% of health expenditure in Australia. Other evidence is also at hand to support action. Information flow among care providers is critical to managing chronically ill people across institutions and over time — these problems are being addressed by the National E-Health Transition Authority. Programs of extended primary care are testing ways of serving the complex needs of patients in the community. There are some (although not many) programs of prevention supported in all jurisdictions or collaboratively through the Better Health Initiative.4 Despite this, no long-term programs engage all sectors of the health and social care system. Pilot projects, most often in general practice and limited in their ability to include specialist, allied health and social care, have flourished briefly, but there has been no serious long-term commitment. Reform in Australian Health Care AgreementsSecond, we need reform in the next round of AHCAs between the Australian Government and the states and territories. These 5-yearly bilateral agreements pledge the parties to public hospital financing. The AHCAs must now build on the developing collaborative spirit of the Council of Australian Governments (COAG), as evidenced in the agreements for the Better Health Initiative. This will not be easy, and to move from the anodyne rhetoric of collaboration to adequately funded action is a big leap. Thus far, there is no indication of sufficient spirit of cooperation within COAG. For example, of the $3.5 billion worth of initiatives in the National Action Plan on Mental Health, many rely on rearrangements of current funding, which might look distressingly like cost shifting. The impact of COAG’s national reform agenda on increased workforce participation by reducing morbidity associated with chronic illness will be minor, at around 0.6%.5 The AHCAs need a new format, outlining how services are to be provided for people, rather than how hospitals are to be funded. It needs to be recognised that funds for chronic disease management are probably five times too low, given that fewer than 20% of patients leaving hospital and requiring continuing care receive best practice care. Medicare rebates for specialist outpatient services may make the funding process more transparent, but they have negligible impact on the necessary integration of care. New funding modelsThird, we need the other instruments of health care payment, including the Medicare Benefits Schedule (MBS), to be aligned with the way sick people require care. Public hospital funding models are based on episodic care for largely independent health problems, and these models continue to be used despite the knowledge that this is not the case for many people admitted to hospital. Patients with chronic illness require continuing care, often increasing stepwise with the addition of increasing social care over years, and involving multiple health service elements from primary care to hospital and back. Health care for people with chronic disorders should be available from a common fund that is spent in line with agreed principles of best practice. The Better Health Initiative pays specialists to integrate services for people with cancer, but continues to rely on incentives for general practitioners to integrate services for people with other chronic illnesses.4 Only medical practitioners can make an MBS claim for case management and care planning, and there are no mechanisms for federal funding for continued and team-based allied health and other interventions to prevent avoidable hospital admissions. Incentives for high quality care for managing chronic disease would be a welcome feature of a reformed MBS. ConclusionThese three steps — a national agenda, a reformed set of health care agreements, and new approaches to funding community-based care — offer one way forward in confronting the rising tide of demand for care of people with serious and continuing illness in Australia. Blame, as we know, is a poor game to play if the object is to seek improved clinical safety and quality. It serves us no better in developing our health policies for tomorrow.

Laurann E Yen BSc, MPsych · Robert W Wells BA · James A Gillespie BA(Hons), PhD · Stephen R Leeder BSc(Med)(Hons), PhD

A call for better data and focused research Surge capacity has been defined as the “health care system’s ability to manage a sudden or rapidly progressive influx of patients within the currently available resources at a given point in time”.1 This term entered the disaster medicine lexicon after “9/11” 2001, and has become a key feature of health disaster planning since the severe acute respiratory syndrome (SARS) outbreaks, the rising threat of pandemic influenza, and the Madrid and London bombings in 2004 and 2005. Mass trauma events in urban environments create surge problems for hospitals in the first 4 hours, with the majority of casualties likely to arrive at hospital in the first 60–90 minutes.2 Health systems need to be able to meet this increased demand after acute mass casualty events, with an influx of patients who may require “specialised evaluation or intervention”,3 including surgery for penetrating trauma. As the epidemiology of traumatic events will differ depending on the cause, any preparations to manage a mass casualty event need to be flexible enough to deal with a range of disaster types, including infectious disease emergencies and bioterrorism, with their more insidious and later-peaking surge. Meeting the challenges of surge capacity enhancement calls for cooperative action at the complex interface between clinical practice, health systems management, logistics, facilities management and personnel deployment. In this issue of the Journal, Traub et al4 quantify the physical assets needed for surge preparedness of Australasian hospitals and conclude that they do not meet United States surge preparedness benchmarks, currently the only ones available. This is the first published study to assess Australian capacity in this area and the need for further research. So what are these US benchmarks and are they an appropriate measure for Australia? The US Health Resources and Services Administration has set a minimum benchmark for surge capacity of 500 adult and paediatric patients per million population for infectious disease events and at least 50 patients per million population sustaining trauma or burns in a mass casualty event.5 These figures have not been validated and, based on other traumatic events, 100–300 patients per million may be more accurate for burns or trauma.6 The consensus from a series of articles on the “science of surge” in the November 2006 issue of Academic Emergency Medicine7 was that there is little or no quantifiable measurement for managing an acute “sudden impact” surge or the even less predictable surge resulting from infectious disease emergencies or obscure events. Even the utility of redundant infrastructure has not been formally evaluated and is known to be costly to bring into operation in response to an incident. In addition, the benchmarks don’t consider the need for management systems to be innovative in dealing with a surge situation. Establishing the exact number of required physical facilities fails to give adequate credence to what is a dynamic, non-linear and complex system. Some of the ways of increasing the capability of hospitals to respond to a local disaster include: creating temporary hospital facilities within public hospitals by having caches of medical supplies and equipment available; using alternative health facilities, such as operating theatres, beds and diagnostic resources in private hospitals and day procedure units for the “walking wounded” and “decanted” patients (patients already in hospital who can be transferred elsewhere to make way for disaster victims); using general and private health practitioners to provide a range of care for the walking wounded and decanted patients; and applying modified models of care, such as longer shifts and extended scope of practice for nurses, allied health practitioners, and medical and other health students.8 Health authorities in various Australian states and territories are putting such arrangements in place as part of their surge planning. Further research to quantify the effect these measures may have on hospitals’ response capability, and whether they can prevent critical bottlenecks, is urgently required. The sustainability of the response is also critical. Some events will overwhelm local capabilities. Having national approaches in place, such as the Australian Burn Plan (AUSBURNPLAN),9 can ensure that appropriate care is provided regardless of the site or prolonged nature of the disaster. The Australian Health Protection Committee and its predecessor the Australian Health Disaster Management Policy Committee have been working since February 2003 to put policies and plans in place to ensure that such a response will occur. A detailed review of the work of the Australian Health Disaster Management Policy Committee until the end of 2005 has been published in the MJA.10 The recent development of the Australian Health Management Plan for Pandemic Influenza;11 the National Medical Stockpile;12 the establishment and deployment to Java, Indonesia, of Australian disaster medical assistance teams in May and June 2006 (in response to the Yogyakarta earthquake); and the improved communication and coordination of health disaster responses between individual states and territories and the Australian Government have all enhanced the national capability to respond to a disaster. What remains, however, is the continuing need for further research in disaster medicine, particularly into surge capacity, so that hospitals and health services can better gauge whether the steps they are putting in place will be effective. Historically, disaster medicine has grappled with the difficulties of evidence-based research, particularly in terms of measuring outcomes through randomised controlled trials. However, without better data and focused research, we will continue to “measure the immeasurable”.

Andrew G Robertson CSC, FAFPHM, FRACMA · David M Cooper MMgt, MBA, FACEM

Inhalation is an attractive alternative to injection, but significant issues will limit its use Insulin is an excellent therapeutic agent with few significant side effects, apart from hypoglycaemia. However, it has one major disadvantage — it needs to be given by injection. Patients’ fears or reservations often mean doctors are reluctant to initiate insulin therapy, even when it is clearly indicated. Not surprisingly, many attempts have been made to find an alternate method of insulin delivery, through nasal, oral, buccal, transdermal or inhaled routes. Inhaled insulin is a theoretically attractive approach, mainly because of the large absorptive surface of the lung alveoli with relatively little proteolytic activity to cause insulin degradation, and it is the most advanced alternative method for insulin delivery in development. One such product, Exubera (Pfizer), has already been granted approval for clinical use in the United States and the European Union, and other products (AERx [Novo Nordisk] and AIR [Eli Lilly]) are in advanced stages of clinical trials. The technology required for administering inhaled insulin is more exacting than that for other inhalation medications, such as those used in treating asthma. As the dose–response curve to insulin is a near linear one, it is critical that the right amount of insulin be consistently delivered to the alveoli and blood stream. The size of the inhaled insulin particles is of paramount importance to this, as particles that are too large adhere to the upper airway and are not absorbed, while those too small will be exhaled before absorption. Manufacturers have used different technologies to address this, and clinical studies have shown that variability of inhaled insulin absorption is similar to that for subcutaneous insulin.1 Pharmacokinetic studies have shown inhaled insulin to be similar to the rapid-onset insulin analogues, such as insulin lispro or insulin aspart, but with a slightly longer duration of action. In other words, inhaled insulin is essentially a rapid-acting insulin suitable for control of postprandial hyperglycaemia. More recent clinical studies suggest that inhaled insulin also slightly lowers fasting plasma glucose levels,2 but the clinical significance of this finding has yet to be fully explored. Inhaled insulin has so far been used in combination with injections of long-acting insulin, and this practice will continue, particularly for patients with type 1 diabetes. In this context, inhaled insulin has been shown to be equivalent to subcutaneous insulin in the control of hyperglycaemia in a number of relatively long-term trials (1–2 years) encompassing all major clinical scenarios encountered in type 1 or type 2 diabetes. However, no clinical trials have shown that inhaled insulin is superior to conventional insulin administration in metabolic control. Clinical trials and theoretical considerations have raised a few potential problems with inhaled insulin, including:3 Insulin delivered via the lungs is more antigenic and results in increased development of anti-insulin antibodies, a problem largely eliminated from conventional insulin treatment by the use of purified insulin. However, these antibodies have not been found to cause major problems, such as allergy reactions or insulin resistance, and they are also unlikely to play a dominant role in the evolution of diabetic complications. Long-term delivery of a foreign substance to the respiratory tract can potentially cause damage. There is little doubt that treatment with inhaled insulin is associated with a small (about 5%) decline in lung function, when measured by parameters such as the diffusing capacity of the lung for carbon monoxide, and forced expiratory volume in 1 second.3 Fortunately, it appears that this relatively minor decline is reversible when inhaled insulin treatment is suspended.4 There is a theoretical increased risk of formation or promotion of cancer with chronic use, especially since insulin is a relatively potent growth factor. This potential danger has not eventuated after use of inhaled insulin in thousands of patients, however it is prudent to carefully monitor for this possible side effect. There are also practical issues with use of inhaled insulin. Smoking immediately before inhalation of insulin increases insulin absorption, although passive or chronic smoking, asthma, and chronic airways disease decrease absorption.4-6 Inhaled insulin therapy is not associated with increased respiratory tract infection but often causes a mild, usually transient cough. Upper respiratory tract infections have shown no significant effect on insulin absorption in clinical trials, but tangible experience is relatively limited. These confounders of insulin absorption have been carefully avoided or controlled in clinical trials, but their potential to cause hypoglycaemia or hyperglycaemia in real-world use is obvious. Some problems with inhaled insulin are highlighted by the commercially available Exubera. Due to its formulation and method of delivery, the dosage of Exubera needs to be measured in milligrams rather than the customary units. It is available in capsules of 1 mg (equal to 3 units) or 3 mg (equal to 8 units), and the product information recommends a commencing dosage based on the patient’s body weight rather than the carbohydrate content of meals. To make things even more confusing, as noted above, three 1 mg capsules are more potent than one 3 mg capsule, complicating interchange of capsules of different strengths. These limitations make minor adjustments in insulin dosage more difficult, especially in patients with labile type 1 diabetes who can develop severe hypoglycaemia with insulin dose adjustment of as little as one or two units at a time. For patients with type 2 diabetes with a high insulin requirement, multiple (more time-consuming) inhalations are needed. Most of the devices used to administer inhaled insulin are relatively large and cumbersome, and they require both time and skill to master. These factors will limit their uptake. In times past, routine tasks in the diabetic clinic included checking the glass syringe, usually carried in an alcohol solution in a special container, and inspecting the needle for sharpness. There has been an obvious improvement in the devices used to inject insulin subcutaneously, and it would be unfortunate if this trend were reversed with the use of inhaled insulin. All these practical issues with inhaled insulin will probably be overcome in time, but at the moment they remain significant. In addition, absorption of inhaled insulin is not as efficient as subcutaneous injection. Indeed, only about 10% of the dose is absorbed. This poor absorption and the high cost of development will inevitably make inhaled insulins much more expensive than their subcutaneous counterparts. This is almost certain to limit their use, particularly in Australia where government subsidy of a new pharmaceutical product largely depends on demonstration of its cost-effectiveness in comparison with existing alternative products. Although qualitative surveys have shown that patients given the choice of inhaled or injected insulin overwhelmingly prefer the former,4,7,8 this has not been shown to translate to wider or earlier acceptance of insulin treatment or a consequent lower glycated haemoglobin level for the diabetic community. The need for caution in the use of inhaled insulin in young patients and the relative lack of flexibility in adjusting dosage by a small amount make it more likely to be used as the initial insulin therapy for patients with type 2 rather than type 1 diabetes. However, for most doctors, who all too often see patients refuse insulin injections when they are needed, the availability of inhaled insulin will be a step forward, at least for some of their patients. In summary, we predict that inhaled insulin therapy will become part of our therapeutic armamentarium, albeit with a small niche market. A small proportion of patients with well controlled type 1 diabetes may use the inhaled route exclusively. Others may use inhaled insulin as a supplement, or to have a much needed “injection holiday”. Subcutaneously injected insulin will remain the major route of administration for the foreseeable future. The inhaled insulins currently available will primarily be used by adult patients with type 2 diabetes who have the financial means — and who are willing to pay — to avoid injections. We suggest that the regulatory authorities could make inhaled insulin available to individual patients for a limited time through the Pharmaceutical Benefits Scheme, to allow patients and their doctors to trial inhaled insulin therapy and assess its benefits.

Aidan McElduff MB BS, FRACP, PhD · Dennis K Yue PhD, FRACP

A giant step forward, but more needs to be done To have lived through a revolution, to have seen a new birth of science, a new dispensation of health, reorganized medical schools, remodeled hospitals, a new outlook for humanity, is not given to every generation.1 An enduring feature of modern medicine is the constancy of challenges and change — and no more so than in medical education and training. In the 1980s and 90s, the Australian medical workforce was deemed to be adequate for the requirements of health services and the community,2 and for more than 20 years there was no political pressure to expand the capacity of our medical schools.3,4 More recently, Australia, along with the rest of the world, has found itself in the grip of a serious medical workforce shortage. This has moved the Australian Government to establish six new medical schools since 2004, in addition to the 11 existing schools. A further five are in the pipeline.5 With this unprecedented expansion, the number of medical graduates is set to rise from around 1600 in 2005 to about 3000 in 2012.5,6 In short, in less than a decade, the number of medical schools in Australia — and their graduate output — will have doubled. Despite the claim that with medical school plurality comes diversity,7 the purpose of our medical schools is decidedly uniform: to produce a graduate who has the attributes and commitment for lifelong learning and a solid foundation on which to build a clinical and professional career. The Australian Medical Council details this foundation in medical knowledge and understanding, skills, and professional behaviour, and notes: “The goal of medical education is to develop junior doctors who possess attributes that will ensure that they are initially competent to practise safely and effectively as interns in Australia or New Zealand, and that they have an appropriate foundation for lifelong learning and for further training in any branch of medicine.”8 Medical education is a continuum from medical school to independent practice, but the prevocational years (PGY1 and PGY2) interposed between undergraduate and vocational training are crucial in the quest for good medical practice and good doctors. And herein lies the rub — the prevocational years have been labelled as a lost opportunity for medical education.9 The factors responsible for this are many and include the apprenticeship nature of training;10-12 an ill-defined curriculum;10 training by time-poor and variably competent teachers;10 variable teacher training;13 the clash between the priorities of service delivery and education;10,12 and variable resourcing of teachers, program supervisors, and the state or territory postgraduate medical education councils.12,14 But at the core of the lost opportunity has been the lack of a relevant and rigorous national curriculum. The supplement “Australian Curriculum Framework for Junior Doctors” published with this issue of the Journal is a giant step forward in bringing much-needed national guidance for Australian prevocational medical training, and celebrates the launching of the Framework by the Confederation of Postgraduate Medical Education Councils in October 2006. The Framework is the outcome of wide consultation with relevant stakeholders and is built on initiatives pioneered by the Postgraduate Medical Education Councils of New South Wales (now part of the NSW Institute of Medical Education and Training), South Australia and Western Australia, and was funded by the Medical Training Review Panel of the Australian Government Department of Health and Ageing. It also draws from the experience of the recently introduced “Modernising Medical Careers” Foundation Programme in the United Kingdom15 and the Royal College of Physicians and Surgeons of Canada’s CanMEDS 2000 Project.16 The Framework, in essence, is a template for education and assessment of performance of junior doctors in the major areas of clinical management, communication, and professionalism (see Box). The Confederation of Postgraduate Medical Education Councils and other relevant players are to be congratulated for making this defining document a reality. It shows what can be achieved with purposeful leadership and effective communication between key stakeholders. But there is more to do! The Framework has to be implemented Australia-wide in hospitals and in general practice. This will require commitment and support from the federal, state and territory departments of health, public hospitals, and general practice. Without this, nothing will change. These agencies need to acknowledge that investment in prevocational medical training now will yield dividends in health care safety and quality in the future. Prevocational education must be a separate entity, not another health service add-on. The need to assess the utility and impact of the Framework is self-evident: will it make a difference? Answers to this vital question will require the elaboration of discerning and measurable outcomes and processes for assessment. The article by Grant in the supplement (→ Changing postgraduate medical education: a commentary from the United Kingdom) outlining initial experience in the UK with Foundation Years 1 and 2 of the Modernising Medical Careers Programme (the equivalent of our PGY1 and PGY2) provides a valuable insight into what not to do: introduce a detailed determination of clinical competence based on multiple observed activities, in the face of insufficient resources and poorly informed and prepared participants.18 Edmonds and Everett (→ Prevocational medical education at the coalface: report from the 2006 notional junior medical officer and director of clinical training/registrar forums) outline the views of junior medical officers, registrars, and directors of clinical training on the Framework.19 Junior doctors caution against failing to include affected stakeholders in its implementation, request that training positions be accredited, and believe that the Framework should be a promoter of teaching and not a barrier to vocational training or another checklist to complete.12 Registrars and directors of clinical training believe that the Framework will add value and resources to current training systems, and improve support for international medical graduates entering the workforce. We continually hear the descriptors “coordinated”, “integrated”, “assessment” and “accredited” applied to the medical training continuum, and to the casual observer it does appear to be a linked and orderly process. But with the expansion of our medical schools, current cracks in the continuum will become wide gaps. Questions now asked sotto voce will become fortissimo; questions such as: Will the medical education and training infrastructure be able to cope with increasing throughput? Despite teaching alternatives such as simulation, the experience garnered by extensive clinical exposure still remains crucial in medical training.9 What are the core competencies of the new medical graduate? How are these to be tested? Should undergraduate and prevocational medical education and training be outcome-focused? With differing medical school curricula and assessments, should there be a common yardstick? Is a national qualifying examination overdue? Are current postgraduate training programs too long and inflexible? Should there be early vocational streaming? Should there be common basic training modules that are transferable between colleges? Should there be part-time and flexible tracks to cater for the lifestyle expectations of modern doctors, especially younger doctors and women? Should there be different competence ceilings for differing levels of specialist training? And there are more. Several experts have poignantly drawn attention to how the Australian medical training sector is fragmented and plagued by limited collaboration and coordination between relevant groups.11,14 Underscoring this is the current situation: the medical schools have their representative body, Medical Deans Australia and New Zealand; the clinical colleges have an overarching body in the Committee of Presidents of Medical Colleges; and the postgraduate medical councils have the Confederation of Postgraduate Medical Education Councils. But despite their good intentions, all are virtual silos with limited interaction beyond their immediate spheres of interest. Is it not time that this insularity is broken down? If not, the drive for reform of Australian medical education and training may come from outside the profession in the form of an overarching government-regulated body.20 As a profession, do we really want this? The Australian Curriculum Framework for Junior Doctors12,17 The Framework is an educational template that identifies the core competencies and capabilities necessary to provide quality health care. It will enable individual doctors to assess their education and training needs. It outlines the general knowledge, skills and behaviour that prevocational doctors should acquire, regardless of their planned specialisation or training location. It bridges undergraduate curricula and college training requirements, and is intended to assist education providers, clinical teachers and employers to provide a structured and planned program of education for junior doctors. It is built around three learning areas — Clinical Management, Communication, and Professionalism — which are divided into varying numbers of categories and topics. Each category comprises a number of learning topics, each of which details the associated capabilities expected. It is envisaged that learning and assessment resources will be made available to support each learning topic.

Martin B Van Der Weyden MD, FRACP, FRCPA

Crystalline methamphetamine usage can wreak havoc in emergency departments “Ice”, or crystalline methamphetamine, is a relatively new drug in Australia. It may be injected intravenously or swallowed, but is increasingly consumed by smoking. With about 1.8 million Australians (9%) reporting ever using methamphetamine and about half a million Australians aged 14 years and older (3.2%) reporting current use of the drug,1 Australia is among the top dozen countries in the world in terms of prevalence of methamphetamine use.2 However, its use varies considerably across the country, being higher in some states — such as Queensland (especially the Gold Coast region), South Australia and Western Australia3 — than others. Reported methamphetamine use increased in surveys of the general population in Australia in the 1990s, but has since declined slightly.4 However, in recent years, indicators of harm (such as psychosis, emergency department presentations, and methamphetamine-related crime) have increased considerably. There was a 59% increase in amphetamine-related psychosis nationally between 1999–00 and 2003–04.5 In New South Wales, methamphetamine-related arrests rose from 18 per 100 000 population in 1995 to 46 per 100 000 population in 2005 (an increase of 253%).4 Why is the consumption of methamphetamine apparently relatively stable, while harms seem to be increasing markedly? Possible explanations for this anomaly include the problems of conducting and interpreting surveys of illicit drug consumption, the increasing purity of street methamphetamine, and the increasing availability and use of more readily absorbed forms of methamphetamine, including ice, which have a far greater psychoactive effect on the brain. Methamphetamine has diverse health and social impacts. These include effects on hospitals, crime, personal relationships, employment and private debt. The nature and extent of these adverse effects have not yet been fully determined. The report by Gray et al6 in this issue (→ Amphetamine-related presentations to an inner-city tertiary emergency department: a prospective evaluation) represents one of the first attempts in Australia to estimate the impact of amphetamine use on a hospital. The authors found that amphetamine-related presentations account for over 1% of all admissions. They involve high-acuity patients who often present with aggressive behaviour, require prolonged emergency department admission and consume considerable resources. They concluded that increasing amphetamine use has had a substantial impact on the hospital emergency department studied. Amphetamine-related presentations are a great burden on the health care system. It can take days before amphetamine-related psychosis can be distinguished from other serious mental health conditions, such as schizophrenia. Knowledge of the full nature and extent of medium- to long-term physical and mental health impairment from street amphetamine use is still evolving. Although we should be wary of predictions that illicit drug problems are destined to deteriorate inexorably and indefinitely, it is likely that amphetamine-related problems will continue to worsen in Australia for some time. In part, the increase in amphetamine production and use may reflect a shift from plant-based drugs (such as heroin or cocaine) to chemical-based drugs, which allow producers to evade law enforcement detection using aerial and satellite surveillance and to avoid the vagaries of the weather. The value of the global market in all illicit drugs for the year 2003 was estimated at US$322 billion at the retail level,7 with the lucrative profits of drug trafficking estimated to account for 26%–58% of turnover.8 Existing alcohol and drug treatment services attract and retain few methamphetamine users, but services that specialise in patients with stimulant problems seem more successful in attracting a higher proportion. The processes of amphetamine withdrawal and detoxification are still poorly understood. Psychosocial interventions (such as cognitive behavioural therapy, contingency management and motivational interviewing) may be sufficient for the many patients with milder problems. But these interventions are unlikely to be sufficient for those who consume substantial quantities of methamphetamine and have severe problems. While many pharmacotherapeutic agents have been tried without success, amphetamine substitution treatment9 appears to be an effective and safe treatment for carefully selected, treatment-refractory patients with severe problems. Drug law enforcement is often touted as a panacea for the problem of illicit drug use, but, as a recent review noted, There is strikingly little evidence that tougher law enforcement can materially reduce drug use. By contrast, drug treatment services remain in short supply, even though research indicates that treatment expenditures easily pay for themselves in terms of reduced crime and improved productivity.10 Accordingly, authorities would be wise to invest more in health and social interventions. New drugs appear frequently in the constantly changing illicit drug industry and are often hailed as “the most dangerous drug yet”. In the politicised and highly charged environment surrounding illicit drugs, it is difficult, but all the more important, to maintain a balanced and evidence-based approach to policy and practice. For many decades, tackling the illicit drug problem around the world has been considered primarily a matter for the criminal justice system. Funding has flowed accordingly, with health and social interventions usually treated as the poor cousins of law enforcement. Yet, in most countries, illicit drug use and consequent problems have continued to increase. The evidence for effectiveness and cost-effectiveness of health interventions for illicit drug use is far more impressive than the evidence for drug law enforcement. It is time that Australia regarded illicit drugs in general, and methamphetamine in particular, as primarily a matter for health and social interventions, although drug law enforcement should continue to play an important role.

Gordian W O Fulde FRACS, FRCS, FACEM · Alex Wodak FRACP, FAChAM, FAFPHM

Treatment targeting vascular endothelial growth factor is revolutionising AMD management Age-related macular degeneration (AMD) is the most common cause of blindness and visual disability in the Western world.1,2 In AMD, vision is lost either from a slow atrophic process (dry AMD) or from a much more rapid and destructive process of choroidal neovascularisation (wet AMD). Wet AMD accounts for the vast majority of severe vision loss. Around 15% of people over 50 years of age (approximately 750 000 Australians) have some signs of AMD, which include pigment disturbance and yellow deposits, called drusen, in the macula. These early changes, sometimes referred to as age-related maculopathy or early AMD, do not usually cause symptoms, but they do increase the risk of developing the sight-threatening complications of AMD (or “late” AMD), which result in 1%–2% of people in this age group losing significant vision. The prevalence of these early changes rises exponentially with age, so that nearly two out of three people who reach the age of 90 will have early AMD, with one in four having a significant loss of vision as a result of progressing to late AMD.1 Including both direct and indirect costs of visual impairment, AMD cost Australia $2.6 billion in 2005, and this figure is expected to grow to $6.5 billion over the next 20 years.3 With its enormous impact on quality of life and economic burden to the community, an effective treatment has been keenly sought. Until photodynamic therapy became available in 2000, clinicians treating wet AMD were confined to the use of destructive thermal laser photocoagulation, which destroys the abnormal blood vessels but also the overlying neural retina. While this treatment was better than the condition’s natural history, it was only used in a small group of patients whose blood vessels were well delineated and not located under the centre of the macula (fovea). Photodynamic therapy, on the other hand, employs a low-powered laser that activates a photosensitive dye to achieve preferential destruction of the choroidal neovascularisation, allowing treatment of lesions under the fovea. Although an advance in treatment, few patients who have photodynamic therapy retain reading or driving vision and virtually none improve on their presenting vision. Further advances in treatment have recently been made, following the discovery that vascular endothelial growth factor (VEGF) is a major driver for the abnormal blood vessel growth in wet AMD.4 There are now many drugs that are directed towards blocking VEGF at various sites in its pathway. These drugs have treatment implications in several diseases, particularly cancers, but their impact is now being felt in ophthalmology, due to unprecedented success in treating wet AMD. Recent publications in the New England Journal of Medicine presented results from two large prospective randomised controlled trials investigating the efficacy and safety of ranibizumab as a new treatment for AMD.5,6 Ranibizumab is a humanised antigen-binding fragment of a recombinant monoclonal antibody directed at the VEGF protein. In the two trials, collectively involving over a thousand subjects, ranibizumab was injected into the vitreous humor on a monthly basis for 2 years, and the results compared with sham injections in one study5 and with photodynamic therapy in the other study.6 In both studies, average visual acuity at 12 months had improved by one line on an eye chart in the ranibizumab-treated groups, compared with a reduction in vision in the control groups.5,6 In the study by Rosenfeld et al, 95% of the ranibizumab-treated group maintained relatively stable vision, compared with only 62% of the sham group. Visual acuity improvement of 15 letters (three lines) or more was seen in about a third of the ranibizumab-treated group, compared with 10% of the sham group.5 Similar results were seen in the study comparing ranibizumab treatment with photodynamic therapy.6 The most feared complication of intravitreal injections — bacterial infection inside the eye — occurred in about one in every 2000 injections, or about 1% of the patients in these studies. Potential systemic side effects from anti-VEGF treatments are arterial thromboembolic events, such as stroke and myocardial infarction. There was no statistically significant difference in the risk of arterial thromboembolic events between the anti-VEGF treatment and control groups in these two studies, but the numbers affected were higher in the treated groups.5,6 Further studies are ongoing to monitor for these adverse events. Ranibizumab was approved by the United States Food and Drug Administration for treatment of wet AMD in June 2006, and, although still awaiting registration in Australia, it is available here through a special Therapeutic Goods Administration access scheme. The current cost of ranibizumab is $2000 per injection (with a subsidy scheme in place after three injection payments). Clinical trials are ongoing to evaluate whether less frequent injections of ranibizumab may be equally efficacious. In current clinical practice, many clinicians have adopted a flexible re-treatment regimen, using visual acuity, clinical appearance and optical coherence tomography scanning of the macula to guide the decision to re-treat. How long treatment needs to be continued remains uncertain, as the underlying disease, and hence the stimulus for new blood vessel growth, has not been addressed by these new treatments. Prior to ranibizumab becoming available, clinicians were already using a related drug, bevacizumab (the full length monoclonal antibody to VEGF derived from the same mouse monoclonal antibody as ranibizumab), to treat wet AMD. Bevacizumab is only approved for use in treating metastatic colon cancer. Although there have been no randomised controlled trials evaluating bevacizumab in the treatment of wet AMD, several uncontrolled case series have reported short-term efficacy and safety similar to ranibizumab.7,8 Off-label use of bevacizumab continues around the world, including in Australia, due to its much cheaper cost compared with ranibizumab. No prospective randomised studies comparing ranibizumab and bevacizumab have taken place, although there are plans for such a trial through the US National Eye Institute. Until the results of such a comparative trial are forthcoming, government and the community face a dilemma of whether to approve and subsidise the well studied but expensive drug ranibizumab, or to delay that decision and therefore condone the off-label use of a drug that has not been submitted to the rigours of a randomised clinical trial nor studied to the extent that we expect before a new drug is introduced. Despite these advances in treatment, our knowledge about the underlying mechanisms and pathogenesis of AMD is still lacking. To date, cessation of smoking remains the most important intervention to reduce the risk of AMD and its progression, especially the wet form. There is still no specific treatment for dry AMD, which leads to a slower, but still significant, loss of vision. Also, our ability to predict and prevent progression of early AMD to the visually devastating complications of late AMD is limited. Achieving this would truly represent a major advance in the treatment of AMD. The recent explosion in publications reporting significant gene associations with AMD may prove a major step in helping us achieve this ultimate aim.9,10

Robyn H Guymer MB BS, PhD, FRANZCO

Careful attention to persecutory delusions of patients and to concerns of family members may help Any homicide is a tragedy, with devastating consequences for all involved, including perpetrators, their families and the community. People with a psychotic illness make a small, steady contribution to homicide figures. Strangers are rarely victims of such events, with family members and others known to the individual at much higher risk.1,2 Other than the impact of psychotic symptoms themselves, the risk factors for violence by people with psychotic illness are similar to those for the rest of the population, and include being young and male, having a background of crime and/or violence, substance misuse, personality disorder, brain injury, and socioeconomic deprivation.3 This issue of the Journal features a case series by Nielssen and colleagues of 10 years of homicides committed by people whose acute psychotic illnesses were considered by the authors to be largely responsible for their crimes (→ Homicide during psychotic illness in New South Wales between 1993 and 2002).4 The authors make two key observations. Firstly, they note that evolving persecutory symptoms in which the subject perceives an immediate threat were highly correlated with homicidal behaviour in their sample. While caution must be exercised in generalising the findings from an uncontrolled series of homicides, selected because their illness was felt to be responsible for their crime, persecutory psychotic symptoms have been repeatedly but not consistently implicated in severe violence in other more rigorous studies.5-7 At the same time, it is clear that most people who experience such symptoms do not act on them.5 It is likely to be a complex and largely unpredictable interaction of risk factors and circumstances that bring about the final tragic outcome. Secondly, in this series, 69% of all homicides occured during the first year of the perpetrator’s illness. The authors raise the possibility that this may reflect inadequate detection and treatment. Although highly plausible, it is not clear from their study how many patients were in treatment at the time of their crime, nor whether that treatment was considered adequate. Other explanations are possible. From a population perspective, the peak age at which people commit homicide and have their first psychotic episode largely overlap.8,9 Therefore, lower homicide rates would be expected in those who are older. Also, family members are likely to be most vulnerable to becoming victims of homicide during a first psychotic episode because they are less attuned to indicators of risk. Further research is needed to clarify the nature of the observed elevated early risk of homicide, but, as the authors conclude, those in the first year of illness are worthy of particular attention regarding risk of violence. Is it possible to predict or prevent homicide by people with a psychotic illness? The accurate prediction of rare events is inherently problematic, with unacceptably low specificity and sensitivity.10 Nielssen and colleagues suggest that: “. . . many of the deaths might have been prevented if the dangerous symptoms had been identified and there had been assertive intervention”.4 Such a statement may greatly overestimate the capacity of mental health services to predict and prevent homicide in the context of psychosis, described by one prominent author as just “part of the human condition”.10 In retrospect, it is often clear where opportunities for intervention have been missed, but this does not guarantee that prevention was possible. This need not, however, be seen as an excuse for nihilism. Careful monitoring and appropriate intervention remain important. As well as preventing homicide, it may be rewarding to focus on the reduction of violence. While accurately predicting violence by individuals is statistically almost impossible, with high rates of false positives, it is possible to identify groups of individuals at high risk of committing violence and by extension, homicide.11,12 Paul Mullen, Director of Forensic Mental Health Services for Victoria, believes that only by intervening intensively and assertively with this often very difficult-to-engage group, and addressing the many biopsychosocial factors that mediate violence in addition to acute symptoms, might it be possible to significantly reduce violence by people with schizophrenia.12 His approach would require intensive, multidisciplinary input and a change in attitude by mental health and other services towards this very challenging group. With luck, such a pathway might reduce violence and occasionally even prevent homicide, while also improving the quality of life of many highly vulnerable people and their families and associates along the way. How then should clinicians proceed when attempting to develop a management plan for a person with a psychotic illness? Clearly, risk assessment necessitates careful enquiry about persecutory symptoms, with an emphasis on the patient’s experience of fear, and consideration of any associated risk to others. Such symptoms need to be considered in the context of other risk factors for violence when predicting risk and developing a management plan. The burden of risk borne by family members and close associates reinforces the need for close and ongoing family consultation. Perceived risk by family members must be taken very seriously and be embedded in the ensuing management plan, which should include direct advice as to how they should respond to actual threat. Because threatening and violent behaviours are rare and complex, predicting and preventing serious violence and, by extension, homicide will always be problematic. Despite its limitations, the study by Nielssen and colleagues reminds us of the need to place grave emphasis on persecutory delusions in the mental state examination, particularly during the early stages of psychotic illness, and to listen carefully to the concerns of family, who remain most at risk of violence. Improved multidisciplinary community mental health services, as are advocated in the early intervention psychosis model, if applied uniformly and rigorously, might go some way to improving the chances of preventing homicide.

Megan J Kalucy BMedSci(Hons), BM BS, FRANZCP · Ross S Kalucy FRACP, FRANZCP, FRCPsych

Is it unethical to avoid using all available information to monitor drug safety? Adverse effects of health care have recently been in the news, from the worrying unexpected cardiovascular risks associated with use of the cyclooxygenase-2 inhibitor rofecoxib (Vioxx) to reports of high percentages of complications following routine surgery.1,2 As medical care becomes more complex, sophisticated and expensive in Australia, it is paramount that we have the best systems in place to monitor its impact and evaluate its safety and efficacy. In this issue of the Journal, Kelman and colleagues acknowledge the limitations of randomised controlled trials (RCTs) in detecting all harmful effects of medicines and make a plea for modernising Australia’s system of pharmacovigilance by building upon the latest technological and data capabilities that we have. They recommend shifting from the existing archaic system of postmarketing surveillance, which relies on piecemeal reporting of adverse events, to a more systematic approach that would include using existing centrally collected, administrative health care databases. Kelman et al claim that by merging information from prescriptions and the Pharmaceutical Benefits Scheme with readily available data on major health outcomes (eg, deaths, hospital admissions, registers of cancer and other diseases), Australia would have a powerful capacity to evaluate the effects of drugs in real-world situations. What are the advantages and disadvantages of such a proposal, and what is happening internationally? The system proposed by Kelman et al has several advantages: The data already exist, and it may even be irresponsible to not use them for important evaluations of health care outcomes; Such data linkage would provide more comprehensive information on both drug use and outcomes and hence would be less likely to be biased than RCTs, which use selected samples with variable participation; The data would cover a large patient population, increasing the likelihood that any adverse effects would be rapidly identified; and It is an inexpensive system compared with very large RCTs or other epidemiological studies, and it would allow greater capacity for pharmacoepidemiology to evaluate the appropriate use of drugs across the whole population. However, there are also potential disadvantages associated with such a data linkage system: There are privacy concerns surrounding the use of individual patients’ data; The analysis and interpretation of linked datasets pose considerable challenges; for example, with common adverse events such as heart attacks or stroke, any associations found must be analysed in relation to other known risk factors, details of which may not be available or may not be accurately reported in the linked data; and There will be costs involved in establishing a national capacity for data linkage. In some jurisdictions, such as Western Australia (through the WA Data Linkage Unit), such data linkages have been carried out for many years, both to evaluate medical care and to conduct epidemiological studies on heart disease, cancer, birth defects, and other health problems.3-5 As a result, the WA Data Linkage Unit and the researchers it serves have considerable experience in linking, analysing and interpreting the complexities of such data, and have developed best practice in relation to privacy concerns. These analyses have had a major impact on improving health services in the state (see Brook et al5 for examples). If all Australian health care data were linked to drug exposure data (from the Pharmaceutical Benefits Scheme), this linkage could provide very precise estimates of the risks and benefits of drugs for the whole population, as well as for subgroups that are often excluded from RCTs, such as children, pregnant women, and people with multiple diseases or other risk behaviours, such as smokers. If linked data are routinely evaluated for outcomes associated with new drugs, adverse events could be detected before considerable harm is done to patients. We must be able to demonstrate to the community that linking data for the sake of the public good does not invade their privacy. Both the National Health and Medical Research Council and the Australian Law Reform Commission are preparing reviews that will help to clarify and, we hope, support these activities. The WA Data Linkage Unit has developed a protocol for linkage that aims to protect privacy.6 This “win–win” approach means that researchers who require linked data on drug exposures and patient outcomes never see any patient-identifiable information. Since the WA Data Linkage Unit’s protocol has been in place, requests for access to identifiable data have reduced markedly.7 When people in the general community were asked if they approved of their information being used in this way, they were found to be not only supportive of it, but they questioned why it was not already being done (C Kelman, Associate Professor in Population Health, Australian National University, personal communication, 2005). Most international developments in pharmacoepidemiology are taking place in the United States, Canada and the United Kingdom, with relevant authorities in these jurisdictions concerned about the safety and cost of drugs, and ensuring efficacy and appropriate prescribing.8 Their recommendations generally support those of Kelman and colleagues. While health care data linkage systems similar to that in WA exist in England, Scotland, the US and Canada, none of these systems are nationwide or have the routine ability to link health care records with drug prescription data; Australia could perhaps lead the world in this regard. We strongly believe that Australia has an opportunity to establish a cutting-edge capacity to monitor its health care system. We also believe that if society has the capability to better monitor the safety of new drugs, it may be unethical not to do so — avoiding the use of information that would help reduce risk to individuals suggests a willingness to allow people to be harmed. At the very least, this conflicts with the physician’s duty to patients to “first, do no harm”. We think the time has come to expect more — not simply to avoid harm and reduce risk to individual patients, but to actively seek to maximise the wellbeing of all citizens. Improved pharmacovigilance is one important step towards this goal.

Fiona J Stanley FAFPHM, MFCCH, FRACP · Eric M Meslin PhD

Surgeons and government must work together to evaluate new surgical technologies Robot-assisted surgery has been evolving over the past decade, from simple adjustable arms to support cameras in laparoscopic surgery, through to the more sophisticated four-armed machines now being installed in a number of hospitals in Australia.1 The name “robot” is somewhat misleading, as these devices do not perform autonomous tasks, but are under the direct control of a surgeon who usually works from a remote console to insert robot-controlled instruments into a patient. This technology has certainly made a number of surgical procedures, such as total prostatectomy and cardiac anastomosis (coronary artery bypass grafting), somewhat easier to perform; however, the true benefit of these interventions is yet to be clearly demonstrated.2 Over the past 150 years, surgery has been driven by technological advances. The introduction of anaesthesia; the development of imaging, from x-rays through to ultrasound, computed tomo-graphy scanning, and magnetic resonance imaging; and the availability in the operating theatre of heart/lung machines, stereotactic-guided imaging systems, and an array of extraord-inary prosthetic inserts for the heart, joints and the vascular system have all meant that surgeons are constantly being challenged by new technologies. The benefits gained from the introduction of laparoscopic surgery into general surgical pro-cedures over the past 15 years have also been possible only through the advances of technology. With these developments has been the need to adapt practice, as new technologies are demonstrated to be of value to patients. Not all new technologies have survived the test of time, however, and some fail on long-term review to deliver on their early promise.3,4 While hundreds of robotic systems have been sold worldwide, there are presently four commissioned robots in practice in Australia. One is located in a public hospital; the other three are in private hospitals. This has caused some concern within segments of the surgical community, as the motives for installing these robotic machines appear to be more commercial and marketing-oriented than based on well established science and surgical benefit. However, since more than half of the surgical procedures in our health system are performed in the private sector, it is hardly surprising that aggressive marketing and commercial interests should be factors in the availability of robotic surgery. Is this in the best interests of the Australian community, the patients treated and the associated cost for the health care system? The purchase price of robotic machines varies but is in the range of $1.5–$2 million.5,6 The costs of disposable items required for a procedure are also substantial, adding a large premium to each surgery performed. If clear and measurable benefits result from robotic surgery, then these costs may be easy to defend and should be supported. But a fundamental issue is why, if the benefits are so tangible, does robotic surgery occur predominantly in private facilities? It may be that the funding is only available within the private sector, or it may be due to a lack of current clear evidence that there is true benefit associated with this technology.7 Indeed, if all the robots were removed from surgical practice tomorrow, the impact on the health care system would not be significant; the overall cost may, in fact, drop. The introduction of robotic surgery has many potential advantages. It makes difficult and previously inaccessible body areas easier for surgeons to access and may lead to decreased morbidity for patients.7 There are exciting prospects for using robotic systems remotely — where the surgeon operates on a patient who is heading to Mars, remotely located in Antarctica, or close to the frontline of a battlefield — none of which are beyond the realms of possibility with the level of technology currently available.8,9 Furthermore, the possibility for surgeons to perform simulated surgery based on a patient’s imaging information and to prepare a range of operative strategies for difficult and complex cases will be greatly facilitated by the availability of robotic systems that are interfaced with computed tomography and magnetic resonance imaging scans and ultrasound information, all brought together in a virtual surgical environment.7,8 We need health professionals who are excited by new developments and new opportunities. Without them we would still be practising surgery as it had been done for hundreds of years. It is unfortunate that our health care system spends much of its energy trying to hold back innovation and development on the basis that funding is unavailable or evidence of benefit is yet to appear. Evidence demonstrating the value of new surgical interventions takes time; its acquisition needs to be properly funded and supported and it needs to be honestly collected and evaluated. Since the Australian Government is the major funder of health care in Australia, and even in the private sector contributes 75% of the scheduled fee for surgical procedures, it has a vital interest in setting up systems where all new surgical technologies (the robot being no exception) are monitored, evaluated and reported on. Most such systems are currently somewhat ad hoc. One exception is the Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S), an organisation run by the Royal Australasian College of Surgeons with funding from the Australian Government to evaluate new surgical technologies (http://www.surgeons.org/asernip-s/). If we are to have cost-effective surgical care that is innovative and relevant, we need the Australian Government to recognise that for all important new technologies, trials are established, data collected and the information fed back to hospitals, doctors and patients. There is clearly a cost involved in such activities, but introducing a poor technology without clear patient outcomes in the long term is a much more expensive activity. The challenge for surgeons and government is to work together as a team, with the surgeons agreeing to appropriate protocols and careful evaluation, and the Australian Government recognising that this innovation needs to be funded from the public purse. “Toys for boys” implies a somewhat frivolous approach to new technologies. This is probably not the case. Rather, surgeons — male or female — are excited by new technologies and the possibilities they offer for the care of their patients. Robotic surgery will become commonplace over the next 10 years. These machines will not replace surgeons, but will provide added precision and enable surgeons to work on difficult cases, regardless of location. The robots will become cheaper, smaller and easier to use. There will be tactile feedback mechanisms and instrumentation integrated into the robot’s arms to enable imaging and sampling to occur at the same time as the procedure is being performed. Just as artificial hips, heart valves and heart/lung machines seemed far-fetched 50 years ago, so too we will look back on this first decade of robotic surgery as the beginning of a major change in the way in which surgery is evaluated and delivered, and care is managed for patients.

Guy J Maddern PhD, FRACS, MS