Editorials

Current data are encouraging, but no reason for complacency Since 1997, when the number of Australians committing suicide peaked at 2720, there has been a sustained reduction in the number of suicides each year. The most recently available figure — 2098 suicides in 20041 — represents an age-standardised suicide rate of 10.4 per 100 000 population, 29% lower than the rate of 14.7 per 100 000 in 1997. The figures are even more striking for people aged 15–24 years, for whom there was a reduction in suicide rates of about 50% — from 19.3 to 9.6 per 100 000 between 1997 and 2004.1 These figures have not achieved the media publicity that they warrant. Although suicide accounts for only 1.6% of all deaths in Australia, it comprises more than 20% of deaths for men aged between 20 and 39 years, and men remain four times more likely than women to die by suicide, with overall age-standardised rates of 16.8 and 4.3 per 100 000, respectively.1 The reduction in male and female suicide rates has been similar: 28.8% for males and 30.6% for females between 1997 and 2004.1 Remarkably, there was a reduction in all 5-year age groups for men and women between 1997 and 2004, except for women in the 45–49-years age group, for whom the rates were 7.0 and 7.1 per 100 000, respectively.1 The highest suicide rates in 1997 were for men aged 15–34 years, and in 2004 the peak was in that same group of men, now aged 25–44 years. This is consistent with a “cohort effect”, with that group carrying forward their increased propensity to suicide, a phenomenon noted previously in Australia in 1983.2 Methods of suicide have changed between 1997 and 2004, with the proportion using firearms reducing from 12.1% to 8.1%. This has been a continuing trend over the past 25 years, although it appeared to accelerate following the enactment of stricter firearms legislation after the Port Arthur massacre in 1996.3 In contrast, hanging has increased from 36.3% to 47.6%. This is of particular concern, as legislating against hanging is difficult, and it probably requires an education program to bring the dangerousness of hanging to the attention of the community. Poisoning by drugs has remained relatively constant (11.4% of suicides in 1997 compared with 10.9% in 2004). This is reassuring and is consistent with recent data, which have allayed previous concerns that use of antidepressants could be associated with suicidal behaviour.4 Naturally, there are always reservations in interpreting data of this nature. The figures are for deaths registered in each calendar year rather than the year they occurred, and about 7% of suicides over the past decade have not been registered until the year after they occurred.1 It is also possible that coronial practices and medical certification of cause of death may have changed. Notwithstanding such caveats, these most recent figures are gratifying, particularly in view of Australia-wide initiatives in the past decade to reduce suicide.5 The question arises of what may have been the reason or reasons for this reduction. The problem in determining this is that there is no clear-cut cause of suicide. Furthermore, even though suicide may seem all too frequent when it occurs, and retrospective analysis may suggest a plausible precipitant, the low base rate of suicide and ethical constraints preclude randomised controlled trials to assess the effectiveness of any one prevention program.6 Nevertheless, it can reasonably be assumed that the causes are several: better community awareness of both the antecedents of suicide and the fact that suicide prevention is possible has probably played a role, along with the provision of more accessible services. More specifically, it is likely that programs promoting better recognition and treatment of depression (the mental disorder most commonly associated with suicide) are paying dividends. That this is so is suggested by the research of Hall et al,7 who found an inverse relationship between antidepressant prescribing and suicide, and concluded: The increase in antidepressant prescribing may be a proxy marker for improved overall management of depression. If so, increased prescribing of selective serotonin reuptake inhibitors in general practice may have produced a quantifiable benefit in population mental health.7 This observation is consistent with the recent report by Ludwig and Marcotte,8 who, after analysing antidepressant use and suicide rates in 27 different countries, calculated that the rate of suicide for those 27 countries would have been 17% higher in 1999 than in 1990, but for the introduction of newer antidepressants. Although these latest Australian Bureau of Statistics data are gratifying, they are no reason for complacency, as illustrated by the increase in suicide in the Northern Territory reported by Measey et al (page 315).9 Furthermore, the general reduction in suicide rates does not negate its tragedy for the individuals and families affected. Continuing vigilance is required, with ongoing acknowledgement and acceptance of the unique role and responsibility that medical professionals, particularly general practitioners, have in identifying and treating the mental disorders, particularly depression, that are associated with suicide.

Robert D Goldney MD, FRANZCP, FRCPsych

We can learn from the US Breakthrough Collaborative, which increased organ donation rates by 20% in 3 years Organ donation saves lives. This trite but true slogan applies to all the solid organs that are currently transplanted. Even in patients with kidney failure, where dialysis provides long-term treatment, the mortality rate is reduced significantly in those who receive transplants compared with those remaining on the waiting list.1 Improved survival, improved quality of life and reduced economic costs of care provide an unusual coincidence of benefits from this therapy. For example, with respect to cost, the recently published Economic impact of end-stage kidney disease in Australia2 contains a careful and conservative assessment of the direct costs of kidney transplantation (excluding costs from comorbidities, transport, loss of income and other incidentals). It reports that the cost of the first year after both live and deceased donor transplants is $62 375, with additional costs related to the donor of $8178 and $3000, respectively. The subsequent annual cost is $10 749 for both types of recipients. These costs compare with an annual dialysis cost of $48 631 for satellite-based patients, $56 828 for peritoneal dialysis, and $82 764 for hospital-based patients (excluding costs from comorbidities, transport, loss of income and other incidentals). Consequently, the cost advantage of transplantation is clear within 1–2 years. However, organ donation and transplantation continue to provoke ethical, legal and clinical debate with respect to procurement of organs from both living and deceased donors. The shortage of organs for transplantation in Australia is a key problem that has been well documented in recent times; it was the subject of an editorial in this Journal just over a year ago,3 responding to a report in the same issue of the adverse impact on Australians arranging kidney transplantation overseas.4 The variability of donor procurement rates between major hospitals was highlighted as demonstrating the potential for improvement. Since that time, the national Australian organ donation rate has sadly remained static at 10 donors per million population. Now, in this issue of the Journal, Opdam and Silvester address the process of organ procurement in hospitals in Victoria and underline the potential for increasing organ donation through change in hospital practice (page 250).5 They describe a carefully performed audit of Victorian hospitals, which assessed the potential for increasing the number of organ donors and confirmed the interhospital variation in donor performance in the Melbourne area. The main issues identified by Opdam and Silvester as opportunities for improving the donation rate were an increase in the consent rate and an increase in the identification of potential donors. Their study found that “there is limited but real potential to increase the number of organ donors in Victoria”. They state that “a maximum practically achievable organ donation rate for Victoria was estimated to be 15 to 17 donors per million population”. This “practically achievable rate” compares to a mean actual donation rate for Victoria of 9.2 donors per million population over the past 5 years. The economic impact alone of an increase of 50% in the donor procurement rate applied nationwide, as conservatively modelled in the report Economic impact of end-stage kidney disease in Australia,2 would be to save $26 million over the next 10 years (apart from an arguably even more important significant improvement in quality of life). There is no reason to doubt that the findings of Opdam and Silvester would apply in all states of Australia — they have been replicated (albeit in unpublished studies) in other states. How then does Australia break the present pattern and lift its donation rate to an internationally accepted benchmark of 15–20 donors per million population? Over the past few years, we have looked to the Spanish experience, but we should perhaps also pay attention to recent activities in the United States, where the organ donation rate has increased significantly. Over about the past 30 months, there has been a sustained rise in numbers, from a national mean of 508 donors per month (before October 2003) to a current mean of 614 donors per month — an outstanding increase of 20% on top of an already respectable rate of 24 donors per million population. Even allowing for the difference in rates of traumatic death between Australia and the US that might affect the number of potential donors, this performance is impressive. The explanation for the improved performance in US donor procurement appears to lie in a sustained strategy, starting in 1997 and culminating in the Organ Donation Breakthrough Collaborative, announced as a national program in April 2003 and commenced in October 2003.6,7 The details of the Collaborative approach have been recently described and can be summarised as an intensive effort to facilitate “breakthrough transformations” in the performance of organisations working together to achieve common goals, based on strategies shown to work in highly successful organisations. A key element is to identify best practices associated with higher donation rates in lead organisations, with a particular focus on early identification of potential donors and the consenting process — factors already identified by Opdam and Silvester as pertinent locally. The methodology of the Collaborative begins with selecting a planning committee of expert teams from hospitals interested in participating, and developing strategies to achieve the target (a “change package”). These strategies are then tested, modified if necessary and implemented. The strategies adopted are guided by what has been shown to work elsewhere and are always multiple in their focus (see Box). The announcement by the federal Minister for Health and Ageing, Tony Abbott, in February this year, that up to 20 of Australia’s major hospitals would be invited to participate in a similar Collaborative, with the aim of increasing organ and tissue donation rates, is welcomed.8 This project, facilitated by Australians Donate (the peak national body for organ and tissue donation for transplantation in Australia), commenced in May 2006 with the aim of building on the US experience. The potential for increase in Australia’s organ donation rate is substantial, as evidenced in the article by Opdam and Silvester. The expected outcome of the Collaborative project is a sustainable increase in the donation rate emanating from more effective early detection of potential donors and a higher conversion rate of potential to actual donors, thus realising the wishes of most Australians to be donors after death.9 There seems every reason to believe that many of the critical “success” factors in the US experience — engagement and commitment of the whole institution, a strong emphasis on support and teamwork of those in the frontline of the process, and a particular focus on an effective consenting process — will also be successful in Australia. The US Organ Donation Breakthrough Collaborative6 Overarching principles Unrelenting focus on change, improvement and results Rapid, early referral and linkage Management of an integrated donation process Aggressive pursuit of every donation opportunity First things/first changes Create a hospital presence or in-house coordinator for the organ procurement organisation Analyse and apply current hospital-specific data Identify a physician or clinician “champion” Conduct monthly reviews of death records Establish clinical triggers for referrals Hold “huddles” for the donation team Identify effective donation “requesters” Conduct after-action reviews Strategies established as successful (“high-leverage” changes) Advocate organ donation as the mission Involve senior leadership to get results Deploy a self-organising team of staff from the organ donor agency and hospital Practice early referral and rapid response Master effective requesting Implement donation after cardiac death

Timothy H Mathew MRACP, FRACP · Jeremy R Chapman MD, FRACP, FRCP

The new National Health and Medical Research Council toolkit is designed to help Effective communication between health care consumers and professionals is fundamental for evidence-based clinical practice.1 Clinicians and consumers recognise how difficult it is to exchange even apparently simple information with each other, while difficulties with more complex information are usually obvious to either or both. With increasing expectations of health care consumers that they will share more in decision making, and with greater access to information of variable quality outside of consultations, including the media and Internet, effective communication during consultations becomes even more necessary than before. One consequence of poor communication between consumers and clinicians is limited understanding by consumers of the benefits and risks of tests and treatments. This can result in decisions that might have been different with better understanding. For example, fewer men are interested in prostate-specific antigen (PSA) testing, and fewer women in adjuvant therapy for breast cancer after receiving more detailed or applicable information about these interventions.2,3 Other strategies that enhance communication have been shown to lead to improvements in understanding. A systematic review found that communication tools in most formats (eg, verbal, written, illustrative diagrams, cartoons and graphs, video, provider-delivered, computer-based) can increase patients’ understanding, especially if they are structured, tailored and/or interactive.4 The style in which data are presented also influences comprehension: “framing” numerical data about benefits and risks of interventions in either negative or positive and relative or absolute ways influences how data are perceived, not only by consumers but by clinicians as well. Addressing these issues has been shown to increase both consumer satisfaction and involvement in decision making, to result in more realistic expectations of outcomes, and to reduce decisional conflicts.4 Better communication contributes to consumer satisfaction in other ways, and with better outcomes. For example, agreement between physicians and patients about diagnosis and management of back pain is not only associated with higher patient satisfaction, but with better health status outcomes as well,5 suggesting that communication which promotes clinician–patient agreement leads to better outcomes. However, the extent to which poor communication contributes to clinician dissatisfaction, and also to other unfavourable outcomes, such as inappropriate underuse and overuse of investigations and treatments, and to health care costs, is unclear at present. There are many barriers to effective communication between health care consumers and professionals. They include physical impairments such as hearing and vision loss; learning disabilities; differences in languages spoken, and in cultural, educational, religious and socioeconomic backgrounds of the clinician and consumer; anxiety; and problems associated with illness and poor literacy. As consumers become more able to access information from an increasing array of sources, the skills of reading, writing and numeracy assume even greater importance. Patients with lower literacy skills are more likely to have problems communicating with health care professionals and to have less understanding about their medical conditions and choices.6 Not all clinicians have the skills to communicate well with a broad range of consumers with differing needs, or to involve consumers in making decisions when consumers want this. In addition, many consumers are not accustomed to having their views heard, or sharing in decisions about their care.7 Implementing better communication also requires negotiation and agreement about the particular arrangements for decision making within specific consumer–professional partnerships.8 The National Health and Medical Research Council has extended and applied the recommendations from two earlier publications to develop a toolkit, based on the best available evidence, to help consumers and clinicians learn the principles for better communication.9 The toolkit highlights common communication problems and provides practical strategies, from both consumer and provider perspectives, for recognising, exploring and solving these problems. The toolkit aims to help both health care consumers and professionals expand their communication skills and use them more effectively in a variety of clinical encounters. The toolkit recognises five principles for effective communication (Box). Each principle is presented in an identical and structured format: background; what the principle means for both health care consumers and professionals; and examples, with tools to put the principles into practice. To apply these five principles, illustrative scenarios, with questions for health care consumers and professionals, and sources of relevant additional information are included. Communicating benefits and risks of interventions between health care consumers and professionals is complex, to say the least. While there is a growing body of research evaluating ways to improve communication between health care consumers and professionals,10,11 we have only just begun to integrate this information into routine clinical practice. Improved communication tools and more effective techniques to overcome the barriers to better communication are likely to result in greater mutual understanding, better decisions and better health outcomes. However, as there is often a long period between communication during consultations and tangible health outcomes, and as the effects on health outcomes may also reflect other interventions and changes, it is easier to establish the effectiveness of communication strategies on shorter-term processes like knowledge, understanding and satisfaction. More research is needed, not only to prove whether communication strategies lead to better health outcomes, but also whether such strategies can be effectively taught and learned. Five principles for effective communication Good communication between health care consumers and health care professionals has many benefits. Health care consumers vary in how much participation in decision making they desire. Good communication depends on recognising and meeting the needs of health care consumers. Perceptions of risks and benefits are complex, and health care consumers and health care professionals may have different priorities. Information on risks and benefits needs to be comprehensive and accessible.

Peter B Greenberg MD, PhD, FRACP · Christine Walker PhD · Rachelle Buchbinder MB BS, MSc, FRACP

Many disparate groups in Australia now concur about the need for continuous food and nutrition monitoring Poor nutrition contributes to Australia’s current health problems in several ways. Heart disease and cancer, both strongly related to nutrition, remain the leading causes of death. At the same time, the prevalence of obesity and diabetes is alarmingly high, and deficiencies of vitamin D, iodine, and calcium are re-emerging. As a consequence, policymakers, food regulators and health professionals need up-to-date and specific information about what people are eating and how much they are eating. They need to know the health and nutritional status of the Australian population. They also need to know how supplies of food and food consumption patterns are changing over time, and what food products contain. In turn, consumer education policies and tools, such as population dietary guidelines and food selection guides, need to be built on a solid foundation of knowledge about the national nutrition profile to reduce the risk of serious nutrition-related diseases and conditions. Food safety regulators also need this information to estimate current exposure to bioactive compounds that may be of concern, such as food additives and contaminants, to inform food fortification policies, and to ensure that nutrition information on food labels is relevant to current consumption patterns. Yet, Australia is unusual among its peers for not having continuous nutrition intelligence. Health-related data about Australians are compiled biannually, but current information about food and nutrient consumption, and trends in these, is conspicuous by its absence.1 The United States, the United Kingdom, and many European nations have had ongoing, systematic programs for monitoring the diet and nutritional status of their populations for many years.2-4 These programs are not confined to large countries with big budgets. For example, in 2001, New Zealand embarked on a 10-year strategic plan for a coordinated national population survey program that includes nutrition surveys in adults and another in children every 10 years, with the next surveys of adults and of children due in 2007–08, and 2012, respectively.5 In contrast, Australia has conducted only three national surveys of diet in the past 50 years: a national dietary survey of adults in 1983, and of children in 1985, and the National Nutrition Survey in 1995, which included both adults and children.6-8 Each cross-sectional survey was conducted by a different agency, using different sampling and collection methods and food composition data. These differences limit our ability to describe trends in food and nutrient consumption.9 Several state and territory governments in Australia have established monitoring systems that survey health behaviours, including food habits.10 These systems provide important information for tracking change, but food production, retailing and consumption are not limited by state boundaries, and information about selected food habits is not a sufficient base on which to build nutrition and food regulatory policy. Those with commercial as well as health interests in nutrition surveillance now favour a new national effort — one that goes beyond the brief encounters of cross-sectional surveys — to provide continuous detailed information on trends in food and nutrient consumption, the food supply and the nutritional status of Australians. Continuous nutritional surveillance must form part of a comprehensive policy to combat nutritional disorders. Where such surveillance exists, such as in the US, the data have been used to evaluate dietary guidelines, revise food selection guides,11 develop and evaluate fortification programs, set “real-life” serving sizes for nutrition information panels on food labels, make decisions about specific food processing regulations, and model the impacts of bioterrorism threats from food contamination.2 The centrepiece of the US system is the continuing National Health and Nutrition Examination Survey (NHANES), which is supplemented by many other sources of data.12 International experience suggests that there are two important actions for Australia to take in developing a food and nutrition monitoring system: 1. Establish a small, affordable, but statistically robust ongoing nutrition survey program, with data collected from a sample each year and reported cumulatively over a number of years. This program should be based within a federal agency that has health information responsibilities, uses consistent methods, can document and maintain databases, and reports on a predictable and timely basis. 2. Create a small nutrition monitoring unit to compile, disseminate and promote the use of all appropriate information about the food and nutrition situation in Australia for various policy, program, and regulatory purposes. The Australian Government Department of Health and Ageing recently commissioned the preparation of a business case for a no-frills national nutrition surveillance system in Australia, and consulted widely with stakeholders on its importance and suitability.13 Many disparate groups in Australia — in food production, marketing, regulation, and consumer health — now concur about the need for continuous food and nutrition monitoring, as well as the imperative to find workable solutions to long-term funding needs. While a national cross-sectional nutrition survey of children is currently being planned, its value would be greater if it were the start of a continuing surveillance program. In this regard, the recent announcement by the Minister for Health and Ageing of $3 million initially for a survey of diet, physical activity, and the weight status of Australian children, and $1 million annually thereafter for the collection of similar data on all population groups in Australia, is welcome, especially if it evokes a matching response from other key data users, including the states and territories.14 This may be the politically propitious moment for a long-term commitment to a system of continuous monitoring of food and nutrition in Australia.

Karen L Webb PhD, MPH · Ingrid H Rutishauser MSc · Geoffrey C Marks PhD, MS, DipNutrDiet · Gregory Masters MSc · Stephen R Leeder PhD, FRACP

Health professionals must create the climate to force politicians to act Australia is in the throes of an unprecedented epidemic of diabetes and obesity. The Australian Diabetes, Obesity and Lifestyle (AusDiab) study found that a million Australians are affected by diabetes, and it provided vital data on Australia’s obesity epidemic.1 Obesity is a driving force behind type 2 diabetes, which has cardiovascular and other complications, such as renal failure and blindness. The dominant effect of weight gain in precipitating glucose intolerance and its consequences suggests that reversal of the “diabesity” epidemic requires a public alert on the need to limit weight gain. The heightened risk of type 2 diabetes occurs at levels of abdominal or general obesity previously regarded as normal. For decades in affluent societies such as Australia, women have been obsessed with their shape and weight. They spend huge amounts of time and money desperately trying to slim, with little effect — men do no better. Meanwhile, the epidemic of both obesity and diabetes shows no sign of slowing. There is a biological component to persistence of the epidemic. The adaptation in hypothalamic control of appetite to reinforce higher food intakes and the endocrine and metabolic thermogenic adjustments with slow weight gain counteract attempts to lose weight.2 Coupled with the modern commercial drive to market unhealthy foods everywhere and seduce us into ever more sedentary leisure, this means we are facing a seemingly unstoppable juggernaut of obesity and diabetes. This epidemic is guaranteed to continue, unless we accept that the decades-long reliance on health promotion and intense media coverage of obesity have had virtually no effect. Dietary advice from doctors has induced only minimal reductions in blood pressure and cholesterol levels, and the results for weight control are probably worse.3 Meanwhile, politicians and health professionals confine themselves to promoting the value of health education. Evidence-based approaches now require us to discard our prejudices and preconceptions and consider converting policymakers and politicians. We must also recognise the influential commercial forces that contribute to an ever more obesogenic and diabetogenic environment. What, realistically, can our politicians do? Australia has a reputation for outstanding obesity research, ranging from public health and epidemiology to molecular biology. However, what is being done strategically about the problem? On the surface, Australia is making what are seen as major investments in promoting leisure time sports and other activities, especially for youth. Presumably, this is based on the recent advice that to cure the obesity problem we need only change input and output by a mere 100 kcal — which seems to be a minute change.4 This implies that all one has to do is get a pedometer to encourage walking, or eat one less slice of bread each day. Unfortunately, there is a dearth of evidence that this works. The current rates of weight gain, varying perhaps from 0.5 to 2 kg/year in the very susceptible, amount to about 10–40 kcal (ie, 0.3%–2% of energy turnover) in the average daily discrepancy between input and output. However, we need to walk briskly for 80–90 minutes daily (ie, about 350 kcal of daily effort) to maintain energy balance on current diets.5 This is a near impossible population goal for leisure time activity. Alternatively, given our current sedentary state, we would need to change to a diet of 20% fat intake with minimal sugary drinks.6 This implies that our hypothalamic regulatory system works to minimise energy imbalance, so the external environmental changes must be of a greater magnitude than the induced energy imbalance. It is ludicrous to expect the whole population — including the disadvantaged — to voluntarily become very active on an optimum diet. Thus, we need to change substantially our living conditions and environment. Our politicians need to accept that major legislative and other regulatory measures are required (see Box). We could arrest the development of obesity in children and adolescents within a year of introducing a coherent program. If the political will is there, then there is hope. The current pervasive marketing to children distorts their understanding, codifies their demands, and transforms their eating, drinking and exercise habits to generate obesity.7 Changing this requires legislative regulation of the marketing pressures (including television and other advertisements which now dominate children’s attention). Parliamentary enquiries in the United Kingdom have revealed that some food and advertising companies may be misleading consumers as blatantly as the tobacco industry did.7 Voluntary restrictions have never been shown to work. Health professionals and their peer organisations must demand that all junk foods and soft drinks be kept out of health institutions, schools and public institutions, as these products can induce as much illness as tobacco.8 They should also go public, demanding political change to transform the school environment and curriculum to improve physical and nutritional education, as well as the food and drink on the premises. In adults, the problem is greater. Nevertheless, a start could be made with statutory food labelling. Currently, labels cannot be understood by consumers nor converted into meaningful units for individuals with different energy needs. Furthermore, health claims are often misleading. Consumers’ views should dominate labelling design (eg, “traffic light” indicators of overall nutritional quality9). A universal display of nutritional health profiles of food products could dramatically change consumers’ choice. In Finland, the introduction of free vegetables and a salad bar with meals sold in canteens and restaurants was associated with a threefold increase in the population’s vegetable consumption. Standards are also needed for the nutritional content of all meals provided within the public sector. The food industry would respond rapidly to new requirements, to ensure continued sales and profits. It is natural that politicians focus on evident benefits within a short parliamentary cycle. But the result is that nothing will happen until health professionals, including the medical profession, engage politicians and media opinion leaders to create a climate that will force politicians to respond to public opinion. Targeting the protection of children’s health, presenting clear analyses of the financial cost of political inertia, and highlighting the need to resist short-term commercial interests is the way to engage high-level politicians. A great example was Tony Blair’s response within 24 hours when Jamie Oliver started soliciting potential votes unless British school dinners improved. The prevention of obesity and type 2 diabetes requires coordinated policy and legislative changes, with greater attention given to our urban environment, transportation infrastructure, and workplace opportunities for education and exercise. Governments — local, state and federal — should commit to optimising opportunities for exercise in a safe environment. A multidisciplinary, politically driven, coordinated approach in health, finance, education, sports, and agriculture can contribute to reversing the underlying causes of the diabesity epidemic. Our medical leaders must recognise their crucial role, and federal and state politicians must look beyond the next election. Is anyone in Canberra listening? Regulatory measures needed to prevent diabesity in Australia Ban all marketing of food to children, including television advertisements. Establish strict food and physical activity requirements for schools. Remove junk foods and drinks from all publicly funded premises. Require “traffic light” food labelling (based on nutritional profiling) on all foods, drinks and meals, wherever sold. Adjust fiscal policies to progressively change the relative prices of foods and drinks high in fat or sugar in favour of vegetables and fruit. Specify urban environmental requirements favouring pedestrians and cyclists.

Paul Z Zimmet AO, FRACP, FRCP(London), FTSE · W Philip T James MD, DSc

Routine infection control strategies are likely to have the most benefit There is increasing concern regarding the possibility of another influenza pandemic arising from genetic mutation or reassortment of the avian influenza strain H5N1.1-3 Governments have stockpiled billions of dollars worth of antiviral agents, even though efficacy may be limited.4 Vaccines are being developed for a disease that does not yet exist.5 Many birds have been destroyed in the hope of preventing a possible future mutation and spread of disease to humans.6 Meanwhile, since the 1918 influenza pandemic, the seasonal winter flu has killed more people than the number who died in the pandemic.7 The recent SARS epidemic was a wake-up call regarding the risk of major epidemics. While important differences exist between SARS and pandemic influenza, the experience of controlling SARS provides some lessons on how to prepare for major outbreaks. It is possible that the next global infectious disease threat will not be influenza. Improving general infection control procedures and preparedness has the potential to improve routine health care on a daily basis as well as improve our ability to manage the next pandemic (Box). The SARS epidemic was not predicted. It took time to recognise that there was an epidemic and then to identify the virus.8 Cooperation among affected countries led to a coordinated effort to improve infection control procedures and limit spread of the disease. The epidemic was controlled largely with basic epidemiological principles of outbreak management and basic infection-control strategies. Hospital infection controlInfection control in hospitals is likely to have the most benefit in controlling a pandemic. The following points need to be considered. Overcrowding: Several of the hospitals affected in the SARS outbreak were suffering from chronic overcrowding (common to all Western countries). Patients were accommodated in beds less than one metre apart and routine infection-control procedures such as hand washing and changing gowns between patients were not possible. Overcrowding in emergency departments, and hospitals generally, inevitably increases the risk of infectious disease outbreaks.9 A separation of at least one metre should be maintained between patients and staff wherever possible. Separation of patients should be routine for all patients with undifferentiated, potentially infectious, illnesses. The easiest way to enforce separation of patients and encourage hand washing and other basic infection-control behaviour is to physically separate the patients in single rooms. Hand washing: Many studies have shown that hand washing protocols are not followed. This is partly related to ward layout, but also involves training and use of innovative solutions, such as staff having small antiseptic lotion bottles around their neck. It does need concerted effort and a culture change. Masks should be used routinely when dealing with patients who have undifferentiated, potentially infectious, respiratory illnesses or any infection that can be spread by droplets or aerosolisation (eg, measles, SARS). It is unclear whether high-performance masks (eg, N95) are needed or whether fit-testing is required, but it is probably more important to wear some type of mask routinely rather than a high-performance mask intermittently. Experience suggests that known high-risk patients represent a lesser threat than an unrecognised patient presenting with what is thought to be a common condition. Both patients and staff should wear masks. Personal protective equipment should be simple, such as disposable gowns, gloves, masks and eye protection.10 Expensive and complicated equipment, if used at all, should be limited to high-risk procedures (eg, airway procedures), as it is difficult to use properly. Design flaws are present in many hospitals. Examples include turbulent ventilation across patient areas and flow of aerosolised gases between treatment areas. Negative pressure rooms are frequently in short supply, if they exist at all, and would be insufficient in a pandemic. Therefore, other strategies are needed, such as physically separating patients, using curtains as separators, and cohorting infected patients as required. The benefits of good infection control were demonstrated during the SARS epidemic, with reduced staff sickness rates and fewer common infections such as gastroenteritis.11 A recent study has shown that in-hospital infection rates with multiresistant organisms are also reduced by good basic infection control.12 Improving day-to-day infection control will also ensure staff familiarity with basic infectious disease principles and allow rapid implementation in a pandemic. It is prudent to ensure that all first-line staff are fully vaccinated for common diseases, and risk assessment should be undertaken regarding other vaccination for staff. Other lessons from SARSEpidemiological skills: Many of the hospitals and communities affected by the SARS epidemic did not have the ability to rapidly deploy skilled staff for epidemiological study of the epidemic as it unfolded. This led to delays in contact tracing and control of the outbreak. Epidemiological skills need to be readily available, either directly through the hospital, or through a regional or national facility. Agreed isolation procedures: During the SARS outbreak, there was little consensus on how to quarantine and cohort potentially affected people — both in hospitals and in the community. Planning and capability to perform these functions should be researched now. Additionally, planning for surge capacity should be part of routine health care planning.13 Coordination and oversight: A poorly integrated public health system meant policies and protocols could vary even in neighbouring communities. Governments scrambled to set up expert committees composed of individuals with varied backgrounds and no history of working together. The absence of legislation empowering governments to compel health authorities and hospitals to comply with directives led to confusion and often incomplete compliance. An agreed regional approach for an infectious disease outbreak is essential; there are many authoritative guidelines.14,15 Equally, the dangers of a profusion of lengthy guidelines must be avoided. Materials must be made available to front-line staff, and should be concise, applicable and accessible. If a major infectious disease outbreak occurs, antivirals and vaccines are unlikely to be effective initially, as it will be a new disease or mutation (whether avian flu or not). Improving routine infection control procedures within hospitals is likely to have a much greater effect on limiting a new outbreak within hospitals, as well as providing benefits on a daily basis to patients and staff. Strategies to limit an infectious disease outbreak from any likely cause Strictly follow routine precautions in hospitals: Hand washing (alcohol/non-alcohol based lotions preferable to soap and water) Wearing of masks, gowns, gloves, goggles Maintaining one metre distance between patients and staff where possible Placing patients with undifferentiated infectious disease in single rooms. Avoid overuse of complicated or expensive approaches, as they cannot be used routinely (eg, negative pressure rooms, isolation suits). Limit exposure to procedures that produce aerosolisation (eg, intubation, nebulisation). Avoid hospital overcrowding, especially in emergency departments. Have a planned approach for isolation and cohorting of large groups of potentially affected people. Develop epidemiological and disease surveillance skills. Ensure staff are up to date in regular staff vaccination schedule. Ensure health system has a sustained surge capacity.

Peter A Cameron MB BS, FACEM · Michael Schull MD, MSc, FRCPC · Matthew Cooke PhD, FCEM, FRCS(Edin)

Clinically useful CAP management guidelines are still elusive Community-acquired pneumonia (CAP) continues to generate controversy. Although CAP is common and generally mild, it can be life-threatening. For the treating clinician there are many questions. How much effort should be directed to establishing the aetiology, given that the responsible pathogen is infrequently diagnosed? Should the patient be managed in hospital or at home? Should one choose older, established antibiotics that work most of the time or broad-spectrum therapy that treats all imaginable pathogens but is probably unnecessary, has a less established safety record and is likely to contribute to increased cost of treatment and the emergence of resistance? To help clinicians with these questions, international guidelines for managing CAP have been published.1-5 However, their clinical usefulness in the Australian health care context is questionable, as they are not based on particularly robust evidence and there is marked disagreement between Europeans and North Americans on the correct approach. The North Americans recommend that extensive investigations should be avoided, many patients should be treated at home, and broad-spectrum antibiotics should be used.1-3 The British and European guidelines are less focused on treating patients at home, suggest the use of cheaper, narrow-spectrum agents, and do not recommend dual therapy to treat both “typical” (eg, pneumococcus) and “atypical” (eg, Mycoplasma, Chlamydophila or Legionella) pathogens, except in patients with more severe illness.4,5 In comparison, the Australian antibiotic guidelines6 steer a middle course, suggesting the use of the Pneumonia Severity Index (PSI)7 to guide the decision regarding the need for hospital admission but then also using the PSI as a tool to assist with empirical antibiotic selection. This latter feature is somewhat unique and is based on local (as yet, unpublished) data. Some authors have suggested that investigations for CAP aetiology are not cost-effective.8 However, these opinions are often based on studies in which sputum samples were of poor quality or were collected after antibiotics were commenced. In most cases, such investigations won’t affect choice of therapy if the doctor treats for both “typical” and “atypical” agents. However, not performing these tests will mean missing the occasional unusual cause of CAP (such as Staphylococcus aureus, Legionella, community-acquired methicillin-resistant S. aureus and gram-negative organisms such as Pseudomonas). Furthermore, for hospitalised patients, the cost of these investigations is minimal compared with the cost of inpatient stay. Neglecting these investigations could lead to inappropriate management of patients who are initially thought to have CAP but who turn out to have an illness such as urinary sepsis or endocarditis. For patients who are sufficiently ill to require admission to hospital, we recommend that at least blood cultures and sputum Gram stain and cultures be performed. Apart from clinical acumen, what other tools can be used to assess the severity of CAP in an individual patient and hence guide the decision on site of care? The two most commonly used CAP severity scoring systems are the PSI7 and CURB-65 (Confusion, elevated Urea, elevated Respiratory rate, low Blood pressure and age at least 65).9 The key purpose of the PSI is to identify CAP patients who could be safely managed at home. However, it is reasonably complex, requiring input of 20 features of patient demographics, premorbid illnesses, initial vital signs and investigation results to calculate the PSI score. In addition, the PSI gives high weighting to patient age and past history but lower weighting to potentially important clinical features such as hypoxia. Thus, young, previously well patients can be classed as having mild CAP (PSI classes I–III), despite being hypoxic and having clinically severe disease. Despite these criticisms, the PSI has been validated on over 40 000 patients and appears to be accurate for predicting 30-day mortality both in the United States and Australia.7,10 For this reason it has been recommended in the current Australian antibiotic guidelines, but its uptake by Australian doctors has been limited.11 CURB-65 has the advantage of being simpler and more focused on the severity of the episode of CAP rather than the patient’s past history. However, a disadvantage is that it appears less useful for determining who is safe to be treated at home.12,13 Neither the PSI nor CURB-65 appears particularly useful for predicting accurately whether an individual patient will require admission to an intensive care unit.14 A recent Australian study suggested a modified version of CURB-65 as being more accurate for this purpose, but this is yet to be validated.15 Given these limitations, clinicians should be mindful that features such as hypoxia, vomiting, poor social circumstances, unstable comorbid conditions and empyema often indicate the need for hospital admission regardless of the PSI or CURB-65 score. Australian recommendations for empirical therapy are much closer to those of the UK and European guidelines than the North American guidelines, promoting the use of cheaper, narrow-spectrum agents such as penicillin and doxycycline.6 It is notable that penicillin is not mentioned at all in the North American guidelines.1-3 The Australian guidelines are supported by the fact that, even in an era in which penicillin resistance appears to be increasing among some Streptococcus pneumoniae isolates, there have been no documented failures of high-dose penicillin in treating pneumococcal pneumonia or bacteraemia. In comparison, there are documented cases of treatment failure with fluoroquinolones, and the widespread use of these agents has been clearly associated with increased levels of resistance to quinolones in S. pneumoniae and other previously susceptible bacteria.16 Given the importance of these issues, a large Australian, multi-state study of CAP is currently under way, with results to be made available in the next 12 months, to better guide clinicians. In the meantime, clinicians may find our general approach to patients with CAP useful (Box). Approach to managing the patient with community-acquired pneumonia (CAP) confirmed by chest x-ray PSI = Pneumonia Severity Index. * Abnormal vital signs are respiratory rate ≥ 30 breaths/minute, heart rate ≥ 125 beats/minute, systolic blood pressure < 90 mmHg. Young patients are less likely to be tachypnoeic. † Hypoxia is defined as partial pressure of oxygen (Pao2) < 60 mmHg or oxygen saturation measured by pulse oximetry (Spo2) ≤ 90% (in patients aged ≤ 40 years, use Pao2 < 70 mmHg or Spo2 ≤ 93%). ‡ Approximate costs: sputum testing, $34; blood culture, $31; Legionella urinary antigen testing, $29.

Patrick G P Charles MB BS, FRACP · Paul D R Johnson MB BS, FRACP, PhD · M Lindsay Grayson FRACP, MD, FAFPHM

We need to know if and when this organism arrives in Australia There is world-wide concern about a new infectious diseases threat following the recent emergence, in Canada,1 the United States,2 and now Europe,3 of a highly virulent strain of Clostridium difficile (called PCR ribotype 027 in Europe and NAP1 in the US). Rates of detection of C. difficile have risen dramatically: at the Centre Hospitalier Universitaire de Sherbrooke in Quebec Province (population, 7.5 million in 2003) in Canada, the incidence among patients aged ≥ 65 years increased from 102 per 100 000 population in 1991 to 867 per 100 000 in 2003.4 C. difficile disease has been more severe, with the proportion of complicated cases in Sherbrooke increasing from 7.1% (12/169) in 1991–92 to 18.2% (71/390) in 2003,4 suggesting a more virulent strain of the organism is emerging. The Quebec Health Ministry reported a total of 7004 cases of C. difficile infection between 1 April 2003 and 31 March 2004, with 1270 deaths (a crude mortality rate of 18%).5 Loo and colleagues1 reported an attributable mortality of greater than 10% in those aged over 60 years — a remarkably high figure. C. difficile is the most commonly diagnosed cause of infectious hospital-acquired diarrhoea in developed countries. Most patients with C. difficile-associated diarrhoea have been exposed to antimicrobials that reduce “colonisation resistance” of the large intestine, allowing subsequent infection with C. difficile. Acquisition of C. difficile is facilitated by its ability to form spores that are resistant to many disinfectants, so that it remains viable in the hospital environment for long periods of time. Toxigenic isolates of C. difficile usually produce two toxins, toxin A (tcdA, an enterotoxin) and toxin B (tcdB, a cytotoxin), which are considered the major virulence factors.6 Some strains of C. difficile produce an additional toxin called binary toxin (CDT). This was first reported in 1988 but not considered important until now.1,2,7 Binary toxin producers make up the majority of the C. difficile strains isolated in the recent large outbreaks of the disease overseas.1,2 A correlation between binary toxin production and severity of diarrhoea has been demonstrated,7 and more community-acquired C. difficile-associated diarrhoea was found to be caused by binary toxin producers. To determine the effects of binary toxin alone, researchers have characterised C. difficile strains that only produce binary toxin (ie, tcdA– tcdB– CDT+ strains). Although supernatants from tcdA– tcdB– CDT+ strains of C. difficile caused fluid accumulation in a rabbit ileal loop after concentration and trypsinisation, challenge of clindamycin-treated hamsters with these strains resulted in colonisation but not diarrhoea or death, suggesting that binary toxin by itself may not cause disease.8 The significance of binary toxin clearly needs further investigation. A second important feature of this “new” organism is that it produces more toxin A and B than other strains. Production of these toxins in C. difficile is encoded by the tcdA and tcdB genes, respectively. These two genes form part of a highly stable pathogenicity locus (PaLoc), a region of the chromosome that also includes the genes tcdC, tcdR and tcdE. Toxin A variant strains fail to produce toxin A detectable by enzyme immunoassay because of a deletion in the tcdA gene. The tcdC gene is a down-regulator of toxin A and B production. The PCR ribotype 027/NAP1 strain has a deletion in the tcdC gene resulting in it no longer down-regulating, and strains produce toxin throughout the log phase of growth instead of just in the stationary phase.9 Non-toxigenic strains lack the PaLoc. The third important feature of these strains is that they are resistant to fluoroquinolone antibiotics, and excessive fluoroquinolone use appears to be a contributing factor in the recent outbreaks.10 C. difficile develops resistance to quinolones soon after exposure.11 Both the newer fluoroquinolones, such as gatifloxacin and levofloxacin, and, somewhat surprisingly, the older one, ciprofloxacin, have been implicated.10 Ciprofloxacin has always been thought of as a low-risk antimicrobial for inciting C. difficile-associated diarrhoea.12 However, once C. difficile becomes resistant to the later fluoroquinolones, it is also resistant to ciprofloxacin, and the resistance trait may become more important for initiation of disease. Another significant finding from the outbreaks reported overseas is the marked variation in C. difficile-associated diarrhoea rates among different age groups. While older people have always been at increased risk, due primarily to decreased host defences, rates in those ≥ 65 years of age have increased dramatically since 2000.13 One possible novel risk factor is exposure to gastric acid suppressants, such as histamine-2 receptor inhibitors or proton pump inhibitors. These agents have been more commonly prescribed in recent years and may be linked with the increased rates of C. difficile-associated diarrhoea in the community,14 although some case–control studies with hospital patients show no association.1,10 The importance of community onset C. difficile-associated diarrhoea was highlighted recently by a report of severe cases in previously healthy people and peripartum women.15 Is this organism in Australia yet? We do not really know because molecular typing is required to distinguish the outbreak strain from others, and this is rarely done. However, it is probably not here — there have been no reports of more severe C. difficile disease, and Australia uses less of the most incriminated fluoroquinolones than other parts of the world. A major problem is that many laboratories in Australia have moved away from culturing for C. difficile, and to save money and time are using enzyme immunoassay kits. C. difficile toxin A enzyme immunoassay kits will not detect strains that don’t produce toxin A, and toxin A + B kits will not detect binary toxin producers. This diagnostic problem is compounded by the fact that laboratories servicing general practitioners often do not examine faecal samples for C. difficile because of the continuing misconception that C. difficile-associated diarrhoea is a hospital problem only. Given the high mortality rate in recent C. difficile-associated diarrhoea cases overseas, it is important that we know if and when this organism arrives in Australia. How could this be achieved? Should C. difficile-associated diarrhoea become a notifiable disease in Australia, as happened in Canada in response to the outbreak there? This is unlikely to be particularly helpful without molecular typing to distinguish the outbreak strain. Targeted surveillance, with one or two laboratories being funded periodically to type a representative sample of isolates of C. difficile from a variety of Australian hospitals, would seem a more reasonable approach. Finally, the value of sensible policies regarding antibiotic use, and good infection control staff and procedures, cannot be over-emphasised. Antibiotic restriction can be effective in reducing C. difficile-associated diarrhoea.16 In response to the outbreak in Canada, the Quebec government recently provided CA$20 million to hospitals in the province to buy additional equipment and hire infection control staff.17 In the long term, such initiatives are likely to have an impact not only on C. difficile-associated diarrhoea but also on other infection control problem organisms, such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus spp.

Thomas V Riley PhD, FRCPath, FASM

The quest for certainty blocks the search for meaning. Uncertainty is the very condition to impel man to unfurl his powers — Erich Fromm General practitioners are many things but, as much as anything else, they are masters of uncertainty. From the problems behind the names on the appointment schedule, to whether the patients will actually show up, how much time they’ll need and what their expectations will be, GPs plunge daily into the great unknown. They take their patients with them. In the cold light of the consulting room, undifferentiated symptoms and a myriad of clinical dead ends can make a mockery of the clean lines of evidence-based medicine — which, after all, is merely a means of quantifying our uncertainty. GPs are called to stand in the breach between their own (justified) uncertainty and their patients’ wish for certainty. So the current uncertainties about the future of general practice, the need to adapt, and the directions for change are probably things most GPs take in their stride. This bumper General Practice issue of the MJA looks at some of the areas of uncertainty and concern. Workforce is a big issue. Many GPs are left wondering at the exodus from general practice and the tendency for existing GPs to subspecialise themselves out of the “general” part of their title. Joyce and McNeil confirm the prevailing impression that, at least among Monash University graduates, fewer new doctors are making the decision to enter general practice. Couple this with the projection for a flat growth in the GP workforce over the next 10 years,1 and the reason for all the uncertainty is obvious. The causes of the workforce shortage have been widely debated. More interesting is the debate surrounding how we should respond. How can we make general practice more efficient and effective? Smart use of information technology (IT) is an obvious avenue. As demonstrated by McInness et al and Henderson and colleagues, IT has been thoroughly pursued by the current cohort of GPs. More than 90% of general practices now use clinical software packages and about two-thirds keep at least some patient records electronically. But there are calls to make more use of computers. According to McInness et al, increasing the use of IT functions such as online decision support, registries of patients and progress notes will benefit patients, especially those with chronic conditions. Dowrick, a UK professor of primary care who has spent time considering strategies for dealing with chronic disease in Australia, echoes this sentiment: General practice will have a key role to play, especially in the early detection of disease and in providing integration and continuity of care. Registers and recall systems for patients with chronic diseases will need to be set up, preferably in electronic form. The Australian Government’s HealthConnect program, which enables health care providers to connect to business grade and advanced broadband arrangements, may provide a useful basis for efficient chronic disease care . . . Primary care teams will have to standardise medical procedures, provide information on local services and make links with patient self-management programs. These activities will need to be carefully coordinated for each patient. Tse and McAvoy and Bolton remind us that we are still far from this IT utopia, but the computers are on GPs’ desks, ready to be used for a variety of applications. Computers are only as good as the information available to them, and another problem in Australia is the evidence base for general practice. GPs publish far less research than their specialist colleagues, are less likely to obtain competitive research grants, and do not contribute extensively to the evidence base of their discipline.2 As noted by Yallop et al, “although improving patient care requires a sound evidence base, rigorously designed studies remain under-represented in primary care research”. This deficiency is at odds with the definition of general practice as “an academic and scientific discipline with its own educational and research base and clinical activity”.3 To its credit, in 2000 the Australian Government initiated a program to address this, with an injection of $50 million over 5 years through the Primary Health Care Research, Evaluation and Development (PHCRED) Strategy. Its purpose was to increase the research capacity of general practice through annual non-competitive grants to academic departments of general practice or rural health; to encourage the development of people with proficiency in primary health care evaluation and research through research development programs; and to establish a flagship — the Australian Primary Health Care Research Institute. The report of an independent evaluation of the PHCRED Strategy became available in April 2005,4 and in December 2005, the Australian Government committed a further $60.4 million to Phase 2 of the PHCRED Strategy, to run from 2006 to 2009.5 However, the evaluation of Phase 1 drew attention to a number of problems: involvement of practising GPs and GP registrars in PHCRED programs was minimal and not long term; an initial hesitancy to make decisions, implement components of the Strategy and elucidate appropriate outcome measures; a lack of depth and breadth in researcher training and development; a paucity of extensive research networks; and instances of suboptimal research relationships between universities and Divisions of General Practice. The need for extensive and effective research networks has long been recognised in the United Kingdom and the Netherlands. Zwar and colleagues argue compellingly for research networks in Australia, putting forward a hub-and-spoke model involving universities and Divisions of General Practice. Central to their plan are academic departments that already have a demonstrated strong role in capacity building; linkages to practice-based research networks through the Divisions of General Practice; and an adequately funded clinical research plan with appropriate remuneration of primary care practitioners for their participation in research. The key to the success of general practice research lies in the extensive involvement of GPs, including research involvement of GP registrars as a mandated part of their training, and the appropriateness of the research question. Indeed, the capacity of GPs’ involvement to make or break a clinical research project is poignantly recounted by Yallop et al. The time has come to test such a model in Australia. It should be open to competition, but restricted to a limited number of consortia so certainty of “proof of principle” is obtained by the end of Phase 2 of the PHCRED Strategy. Linkages between universities and Divisions of General Practice will be critical to this model — an issue explored by Kalucy and colleagues. Finally, if we are to ensure success at the end of the current PHCRED cycle, oversight by a national advisory committee composed of appropriate stakeholders will be imperative.4 Its absence in Phase 1 of the PHCRED Strategy is baffling. Strong general practice is “patient centred, consistently of high quality, safe and accountable”.6 In reality, this means using data to identify, learn from, and prevent error and system failure. In the interests of improving safety in Australian general practice, Makeham et al used data reported anonymously by GPs to surmise that about one error is reported for every 1000 Medicare-billed patient encounters, and about two for every 1000 individual patients seen. With similar intent, Hutchinson and Watts report on the acceptability of the complaints register component of the RACGP Standards for general practices. They found considerable variability in the use of complaints registers, but that GPs were not overwhelmingly adverse to their use. Both these studies indicate there is a healthy attitude to exploring indicators for safety in Australian general practice. There are many indications in this special issue of the Journal that general practice will move beyond the current uncertainty to emerge transformed but strong. We asked Jackson, and Harris and Harris to tell us what Australian general practice might be like in 2020. Both identified the need for a strategic approach to change, so that the GP’s role remains central in a society with changing needs, expectations and resources. In the future, what will make a good GP? In Dorothy H Cohen’s book The learning child,7 published in 1972, US educationalist Robert Havighurst is quoted as saying: The modern world needs people with a complex identity who are intellectually autonomous and prepared to cope with uncertainty; who are able to tolerate ambiguity and not be driven by fear into a rigid, single-solution approach to problems, who are rational, foresightful and who look for facts; who can draw inferences and can control their behavior in the light of foreseen consequences, who are altruistic and enjoy doing for others, and who understand social forces and trends. We are products of the modern world. The scenery has changed. But a good GP will be what a good GP has always been — a master of uncertainty.

Ruth M Armstrong BMed · Martin B Van Der Weyden MD, FRACP

Why try a doctor when you need a dentist? Oral conditions have some of the highest prevalence and incidence rates of all health problems in Australia.1 They are frequently associated with pain, functional limitations and interference with usual activities. Most people experiencing oral symptoms will visit, or at least contemplate visiting, a dentist. But why are some patients with oral conditions presenting to general practitioners? While signs and symptoms associated with dental caries and periodontal diseases are usually understood to be problems for dentists, sequelae of these conditions, such as abscesses, facial swelling, altered taste and halitosis, may sometimes be considered more of a medical than an oral problem. Furthermore, differences in the way dental and medical services are organised and delivered may provide a greater incentive for patients to present to GPs rather than dentists. This applies not only to conditions for which an ill-defined boundary exists, but also for management of acute symptoms of common oral conditions. Mansour and Cox outline some of these common oral conditions in this issue of the Journal (page 64).2 One result of the evolution of the medical and dental professions over the past century is a “separateness” that has diminished both professions’ understanding of the other’s discipline. While it is highly desirable to reduce this knowledge gap, it seems unlikely to be readily closed, given the existing curriculum pressures created by scientific and technological advances. A logical response to the inappropriate presentation of patients with oral conditions to GPs would be to both remove the incentives for this type of presentation and to provide more certain pathways for dental referral when they do occur. Indeed, Mansour and Cox recommended dental referral for most of the cases described and for all possible outcomes of their decision-making algorithm. But while the need for referral to dentists is generally well recognised, the ability to refer may be limited. Both the initial presentation to a GP and the difficulties in referral to a dentist are shaped by problems in accessing dental care in Australia. There are only about 9000 practising dentists in Australia (approximately 50 per 100 000 population),3 the vast majority of whom work in either the central business districts or middle-class residential suburbs of the major population centres, leading to significant maldistribution. Equally important is the fact that 86% of dentists work in the private sector, where they alone determine location, hours worked and fees charged. Outside normal business hours, the number of available dentists is very limited, and access is frequently restricted to existing patients of a practice. In some instances, major public hospitals and the limited number of dental hospitals do provide after-hours access to on-call dentists, but this is the exception rather than the rule. Publicly-funded dental care is usually restricted to holders of concession cards, which reduces those eligible to about 34% of the adult population. Further rationing of dental treatment occurs because of the limited facilities and shortage of dentists in the public sector. Only 19% of eligible dentate adults (ie, those with natural teeth) receive any dental care from public dental services in any year.4 An overall shortage of dentists makes access to dental treatment even more difficult. Within 4 years, Australia is predicted to be short of some 1500 dental care providers, mostly dentists.5 This shortage creates a bottleneck in the supply of dental treatment. It is most harshly felt by people already having difficulty obtaining dental treatment — low income Australians and those living in rural areas. However, the bottleneck also extends to dentistry in the “main street”; that is, private general dentists in middle-class residential areas. Increasing the number of positions in our universities for dental students may eventually overcome this problem — assuming there are academics to teach them and funding to competitively employ some of them in the public sector at the completion of their education. However, the current national output of less than 250 graduates a year does not begin to address the shortfall. Increased education of auxiliary dental personnel (hygienists and therapists) should lead to increased prevention programs, but is unlikely to address the problem of adults presenting with acute conditions. Cost is another significant barrier to accessing dental care. An estimated 25% of dental patients delay seeking treatment because of the expense.6 Public funding for dental treatment is dramatically less than for medical treatment. At present, public funding from the federal government is directed at the 30% private health insurance rebate, while state and territory government public funding is directed at low income adults and schoolchildren. The outcome is an inequitable pattern of public assistance in accessing dental treatment. Ironically, the average taxpayer may well pay the most and receive the least in terms of support in accessing dental treatment. The majority of patients will face the full cost of any dental treatment. The current average hourly rate for dental practices is $350 (of which overheads represent 73%).7 Thus it is likely that any substantial care (be it diagnostic or therapeutic) will represent a significant financial burden to the patient. The incentive for patients with oral conditions to present to a GP is obvious. GPs are more available, obtainable out of hours, and can be seen without the need to pay substantial out-of-pocket costs. The corollaries of these same issues are often the substantial barriers to dental referral for patients presenting to GPs. Recently, the federal government recognised the need for dental care among patients with a GP Management Plan and Team Care Arrangements or an Enhanced Primary Care multidisciplinary care plan. Essentially, approved patients may be referred to a dentist for an assessment and two other services within a 12-month period. In 2005, there were only 2055 referrals for dental assessment (Item 10975),8 and these resulted in 2500 items of treatment or referral to a dental specialist (Items 10976, 10977). The total cost of dental diagnostic and treatment procedures was just over $500 000 (or $250 per 100 000 population). These data indicate a negligible level of referral under these plans. Specific issues within these plans act as further barriers to referral for dental care. For GPs, the cost and time involved with administrative requirements far exceed the value of the remuneration. Referral cannot proceed until the original care plan has been completed and paid for, which largely negates treatment of acute conditions. The relatively small number of appointments permitted, dentists’ unfamiliarity with the Medicare remuneration system, and the level of remuneration make dentist participation professionally and financially unrewarding. The result is that current referral plans available under Medicare are unlikely to provide a simple or effective pathway for dental referral and treatment. Currently, patients with acute oral conditions should hope that the problem occurs during normal hours in a major population centre, that the condition is not part of a larger problem, and that they are wealthy enough to have a regular dentist who has the time to see them. For patients who are not so fortunate, presentation to a GP is likely to remain an option. As outlined by Mansour and Cox, on most occasions, little, if any, effective help can be offered beyond referral to a dentist. The short-term results are frequently only palliative, at best, and without appropriate follow-up care — resulting in increased costs to the public purse and ongoing suffering to the patient.

Roderick I Marshall BDSc, MDSc, FRACDS(Perio) · A John Spencer MDSc, PhD, MPH

There is a considerable mismatch between evidence and policy The Australian National Chronic Disease Strategy The National Chronic Disease Strategy is a nationally agreed agenda to encourage coordinated action in response to the growing impact of chronic disease on the health of Australians and the health care system. It has five health priority areas: asthma cancer diabetes heart, stroke and vascular disease osteoarthritis, rheumatoid arthritis and osteoporosis. It is structured to reflect the phases of illness: reducing risk finding disease early managing acute conditions long-term care care in the advanced stages of disease. Implementation of the strategy will be the responsibility of individual jurisdictions. Chronic diseases now have a major impact on Australian society, accounting for about two-thirds of health care expenditure (more than $35 billion) in 2000–01. Last November, the Australian Health Ministers’ Conference endorsed a national strategic policy approach to manage and improve chronic disease prevention and care in the Australian population. The approach has three elements: a national chronic disease strategy; a set of five national service improvement frameworks; and a blueprint for nationwide surveillance of chronic diseases and associated determinants.1 The policy focuses attention on five chronic disease groups: asthma, cancer, diabetes, cardiovascular diseases and musculoskeletal conditions. These have been identified because they are common and lead to substantial levels of disability among Australians. The authors propose a multilayered strategy aimed at preventing or delaying the onset of chronic diseases, intervening early in disease processes to minimise harm and improve quality of life, ensuring integration and continuity of care, and encouraging the active participation of people in their own health care. People living with chronic medical conditions are clear about the elements they require from a modern health care system. They need access to high quality information about their condition, care which is continuous and well coordinated, effective management of their symptoms and — perhaps most importantly — help in managing the social, economic and psychological consequences of their symptoms.2 This ambitious Australian strategy is timely and well considered. If successfully implemented, it will go a long way towards meeting these requirements. The key question is, what must be done to translate it from a worthy set of words to an effective set of deeds? What steps must be taken to give it the best chance of success? First, there is a need to promote chronic illness on the agendas of policymakers so that the necessary political and economic changes can be made to the Australian health care system.3 Structures must be put in place to reduce health care inequalities and to maximise efficient resource allocation. It is not yet clear whether such structures are best situated at federal or at state level, nor what role the private sector should play. Assuming a degree of competition is both inevitable and healthy, it may be best to base such decisions not (as historically) on answers to the question “who pays?”, but rather on answers to the question “who provides best value?”.4 Second, primary health care must change. General practice will have a key role to play, especially in the early detection of disease and in providing integration and continuity of care. Registers and recall systems for patients with chronic diseases will need to be set up, preferably in electronic form. The Australian Government’s HealthConnect program, which enables health care providers to connect to business grade and advanced broadband arrangements, may provide a useful basis for efficient chronic disease care, insofar as it enhances the ability of health providers to share information about patients.5 Primary care teams will have to standardise medical procedures, provide information on local services and make links with patient self-management programs. These activities will need to be carefully coordinated for each patient. Australian general practice is not currently configured to deliver this strategy to maximum effect. Models of good practice, such as the South Australian HealthPlus experiment,6 show what can be done with the injection of energy and imagination, and the provision of adequate resources (particularly at the care coordination level), but there remains a substantial mismatch between evidence and policy.7 It will be necessary for managers and practitioners to resolve the complex structural problems inherent in realigning a fee-for-service system that is designed to provide acute medical care towards a managed care system which must inter alia provide adequate financial support for high-quality electronic information systems, and generate funding models which enhance multi-disciplinary care rather than encouraging individualistic approaches to health care delivery. Recent policy developments in the United Kingdom offer useful guidance, and provide evidence for their success.8 Third, new programs of education will have to be put in place for patients and carers, and also for health professionals. Education for patients and carers can be provided to an extent through the mass media or via the Internet,9 but the main focus is likely to be through the expansion of facilitated self-management or “expert patient” programs.10 It is important to ensure that such programs enable patients with chronic diseases to actively engage in promoting their own health, and to make effective links with relevant health professionals. They must also avoid the tendency of becoming the preserve of a motivated minority, as this increases the risk of health inequalities.11 The focus of health care education has already begun to change, with a gradual shift of location from hospital to community, and increased recognition of the value of scientific perspectives drawn from psychology and sociology. Learning outcomes also need to be reviewed, as symptom control and quality-of-life issues become the priority in effective management of chronic medical conditions. The next generation of health care professionals will have to become more experienced in pain management and in understanding the psychosocial aspects of long-term conditions, the needs of carers, best practices for coordinating care, and how to work well in partnership with patients.12 Finally, there will be a need for new research. Care coordinators are likely to be central to new models, but we do not yet know enough about their best role definitions, nor their economic costs and benefits. Do self-management programs work best when run by and for patients, or when they habitually involve health professionals? What are the principal barriers to a reorientation of general practice to meet the needs of patients with chronic diseases, and how can they be overcome? Questions about the cost-effectiveness of new models of chronic care also need to be asked. To address these questions, researchers must better understand the context in which they are operating: how health care functions as a complex adaptive system,13 and the processes which enable (or hinder) the implementation of new technologies into routine clinical practice.14

Christopher Dowrick BA, MD, FRCGP

Caring for those who cannot or will not care for themselves In discussions and studies about access to health care — from prevention to inpatient management — the lower end of the socioeconomic spectrum rarely rates a mention. This sizeable subgroup, especially in cities but also in rural settings, is over-represented among people attending emergency departments.1 Frequent attenders to emergency departments are a heterogeneous group — a mix of patients with chronic medical, mental health, alcohol and drug problems, as well as other psychosocial issues.2,3 Individual patients often have a combination of some or all of the above problems. Interestingly, the frequency of attendance may change with time, although patients with psychiatric and substance misuse issues tend to be persistent heavy users.4 Despite the fact that they may be as sick as other, non-frequent attenders, frequent attenders are often perceived as time-consuming “illegitimate” users of emergency department resources.1 From the patient’s viewpoint, despite having good access to primary health care, the emergency department is seen as the most appropriate place to seek help because of a perceived need for urgent care.5 Rather than as a substitute, emergency departments are often used in conjunction with primary care services, with the emergency department providing appropriate higher level care.6,7 Some of the debate about the resourcing of very expensive 24-hour services, such as stressed emergency departments, focuses on “diverting” patients away or “streaming” them somewhere else (eg, general practice) after appropriate triage. Multidisciplinary teams (including allied health workers) that target high-risk patient subgroups — the elderly, patients with respiratory illnesses, patients with mental health problems — have been introduced in many hospitals to address the swamping of emergency services. But does all this actually make a difference? In this issue of the Journal, Phillips et al (page 602)8 evaluated the effect of multidisciplinary team case management on frequent attenders’ utilisation of an inner city emergency department in Melbourne, compared with their utilisation before case management (ie, the study population acted as their own historical controls). Emergency department utilisation and scores for housing stability, alcohol and drug use, and primary and community care engagement were determined. Perhaps surprisingly and paradoxically, despite intensive case management, Phillips et al found an increase in emergency department utilisation and overnight stays. A potential interpretation of this increased utilisation is that it may well reflect an increase in engagement of these patients, with the desired increased attention and improvement in their health. Furthermore, the study found that linkage with primary care and community services improved. Interestingly, in 2002, Moss et al, at another Melbourne inner city emergency department, found that a similar strategy produced a significant fall in hospital admissions.9 In an ideal world, there would be no debate about allocation of care teams to sick patients or the effectiveness of preventing health deterioration. Nor would certain groups of patients only be really visible once they have deteriorated — and then only mainly visible to certain parts of the health care system (eg, emergency departments, and community and mental health services). In health care, as elsewhere, planners can largely underestimate the need for, and the effect of, a new service where none previously existed. This would be easy to imagine when dealing with a marginalised, and at times psychosocially challenged, group of people. Quoting Malone: . . . reducing unwarranted or unwanted emergency services utilisation is not merely a matter of redirecting individuals to other medical care providers but is lodged within the larger and far more complex issue of how and where we as a society and as individuals care (or fail to care) for those who cannot or will not care for themselves in socially sanctioned ways . . .1 Research, measuring appropriate outcomes including accurate assessments of cost, has to be increased to allow resources to be rationally allocated.

Gordian W O Fulde FRACS, FRCS, FACEM · Martin Duffy MB BS, FACEM

The responsibility lies with the scientific community Since, both in importance and in time, health precedes disease, so we ought to consider first how health may be preserved, and then how one may best cure disease. Galen, AD 130–200 The article on scientific misconduct by Gerber in this issue of the Journal calls for more vigilance on the part of editors and peer reviewers in exposing fraudulent research.1 A recent commentary in the New York Times also vigorously questions the merits of peer review and the role of scientific journals in light of recent disclosures of fraudulent research published in high level journals and asks for more credibility on the part of editors as science gatekeepers.2 All this begs the question: why do editors and scientific journals come into the spotlight each time there is a new and shocking discovery of scientific fraud? Are they really the guilty party for publishing fraudulent research articles? As articles in scientific journals are the main form of scientific communication and documentation of research,3 members of the public mostly see scientific fraud as a deficiency in the publication process and focus on “the messenger” rather than on the true causes of scientific fraud. Instead of considering how to preserve the “health” (ie, responsible conduct) of research,4 it is left to editors and peer reviewers to look for ways to treat the “disease”. Is this fair, especially in view of the fact that scientific journals have been instrumental in gathering evidence about fraudulent science3 and in detailing problems of peer review and publication?5 Their evidence, and the exposure of each new case of scientific fraud, increases the awareness that this issue must be very seriously and creatively considered by the whole research community — not only at the end stage of the research by those involved in the publication process. Although many say that fraud is a substantial problem and blame editors for downplaying its significance,1,2 when we look for evidence, the estimated prevalence of fraudulent articles in international journals is about 0.2% of published articles.3 The prevalence of fraudulent articles may be higher in smaller journals with little scientific impact,6 but their authors rarely get discovered because the articles are either not read or not cited by the wider scientific community. An important element of scientific misconduct is the personal responsibility of individual scientists who are involved in the research and whose names ultimately appear on the published article. The Hwang scandal clearly illustrates that, although all authors usually get the same or similar benefits from a published article, the authors are not the same in the face of scientific fraud: many are quick to accept praise and benefits flowing from a high-profile publication, but many also evade the responsibility we expect from all authors — responsibility for their published work.1 Even the International Committee of Medical Journal Editors (ICMJE) has pulled back from its strict requirement, in the 1988 revision of the Uniform requirements for manuscripts submitted to biomedical journals (URM), that “each author should have participated sufficiently in the work to take public responsibility for the content”.7 The requirement in the current edition of the URM8 is that “each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content”. The move away from requiring shared responsibility of all authors for the whole manuscript opened a loophole for authors of fraudulent articles to escape embarrassment and perhaps legal action, as they can always claim that they were not responsible for the questionable part of the research. This was the case with Professor Schatten and the University of Pittsburgh in the Hwang case.1 Schatten was an advisor in the research conducted by Hwang and colleagues. Although he was listed as a co-author on the offending articles, he, unlike Hwang, was found guilty of scientific misconduct rather than fraud. We believe that the change to the ICMJE authorship criteria was a wrong move by the editors who defined such criteria. Wouldn’t it be better and more natural for all authors of a manuscript to meticulously analyse data produced by their team and ensure the veracity of the evidence presented, rather than transferring this responsibility to editors and reviewers? In the absence of this process, it is not surprising to see strong criticism of journals, editors and the peer review process and to hear demands that key data for most manuscripts be made available to reviewers.1,2 Although this seems like a rational proposal, it would have to be counterbalanced by ensuring that the reviewers, who are often the authors’ competitors in the field, do not misuse their privileged access to the data. The process of scientific discovery is a human endeavour and, as such, is burdened by the imperfections of human nature and ability. In other words, a degree of dishonesty can and perhaps must be expected in this process. The system of entrusting money to someone (a scientist or group of scientists) to do research contains an inherent imperfection: there is no guarantee that the endeavour will succeed, because it aims towards the unknown. Consequently, the key principle of scientific research is relatively poorly founded trust. Having trust as the only safety mechanism leaves the research process open to the risk of failure — and fraud. Trust and honesty present one side of the equilibrium of scientific integrity, and have to be balanced against pressures for publication output. To use an analogy with the economic rationalisation for crime,9 scientific fraud can be considered as a rational act of balancing the expected utility of scientific promotion against the expected cost of punishment. If we want a fraud-free equilibrium, the scientific community must find ways to ensure that the costs of fraud and assisting in fraud are high while the cost of informing about fraud is low.10 That is why the problem of scientific fraud cannot ultimately be solved by better peer review or more stringent editorial processes.11 It requires active and preventive work by all those involved or affected, starting with the research and academic community itself.4,12

Ana Marušić MD, PhD · Matko Marušić MD, PhD

An innovative model for health planning has improved equity of access and outcomes Clinician frustration with marginalisation of their influence in the public hospitals and a growing mistrust of centralised bureaucracy reached boiling point in New South Wales in 1999. In response, the then Minister for Health established a program aimed at re-engaging clinicians in the governance of health services. One outcome of this engagement was the emergence of an entity, unique in the Australian context — the Greater Metropolitan Transition Taskforce (GMTT). At the core of this entity was clinician-led responsibility for the development of networks and plans for clinical services across a population of five million people. Two complimentary, independent reviews1,2 of the outcomes of the GMTT led to the permanent establishment of its successor, the Greater Metropolitan Clinical Taskforce (GMCT), in 2005, and the current search for a full-time clinician chief executive officer to carry it to the next phase. It is timely to review the achievements and outcomes of the GMTT (Box) and the relevance of these to future clinician involvement in health governance across Australia and, perhaps, beyond. At the heart of the GMTT experiment was the conviction that busy clinicians working under trying circumstances would, nonetheless, accept the challenge to join a collegial effort to network their services and accept responsibility for master planning for more equitable delivery of their particular specialty. The GMTT vision for clinician governance required doctors, nurses and allied health professionals in a particular specialty to meet and plan in a “first among equals” environment. Although many involved doctors knew their colleagues from scientific meetings, few had ever met to plan metropolitan-wide services and none had done this with nurses and allied health colleagues. An innovative aspect of the process was the appointment, as initial network chairs, of clinicians who did not belong to the discipline (eg, the cardiologists’ group was chaired by a gastrointestinal tract surgeon). After initial hesitancy, 17 designated networks formed and flourished. In 2002, the GMTT received $64 million from the NSW Government to deliver the 162 service improvements designed by the clinicians,3 on the condition that they function as metropolitan-wide networks. The money was necessary for change, but far from sufficient. Each network elected its chair and co-chairs. Critical to success, each was supported by clinician-managed infrastructure, including a senior network manager. Consumers were appointed as equal members to the executive committee of each network and to the GMTT committee, adding an important element of community scrutiny. The GMTT was strongly endorsed in an external review in 2003,1 and the activities of the GMCT have attracted interest from, and degrees of replication in, other states in Australia and in New Zealand. Internationally, there is growing interest in, and experience with, managed clinical networks as a means of counterbalancing some of the shortcomings of the current hierarchical systems of health service governance.4 The GMTT model and process were outlined in a commentary in the Lancet in 2004: “Turning the health system 90° down under”.5 In 2005, the networks were confirmed as the peak bodies advising NSW Health, the Director General of Health and the Minister for Health on all clinical matters relating to their field; this followed recommendations from a second external review (the Phelan review).2 Other essential ingredients of the success enjoyed by the taskforce include the commitment to meaningful consumer involvement and a continuing program aimed at increasing understanding and cooperation between “front line” clinicians and middle managers. Of particular importance have been partnerships with newly created organisations whose missions overlap with that of the GMCT: the Clinical Excellence Commission (CEC; a peak body established to improve quality and safety in health care in NSW), the Institute of Medical Education and Training (responsible for postgraduate training and a more equitable distribution of trainees) and the newly formed Cancer Institute NSW. The CEC in particular has valued the single point of entry to clinicians in a whole discipline that a GMCT network and program manager offers. Increasingly, the GMCT is working in concert with the Rural Health Taskforce to improve patient outcomes across NSW. Currently, more than 4000 clinicians are committed through the networks to the GMCT process and structure.6 They have used their networks to enhance equity of access, particularly in outer Sydney, with a range of new services from acute stroke units to interventional cardiology.6 There is good evidence that the stroke units have achieved significant improvements in the care of stroke patients. Similarly, the establishment of interventional cardiological procedures at several hospitals has led to a major improvement in the standard of care for patients presenting to those hospitals with acute coronary syndromes. Other clinicians have used their networks to eliminate waiting times for living related donor renal transplantation from 18 months to zero; to provide uniform clinical protocols across five million people (examples include web-published protocols for prioritisation and treatment for bone marrow transplantation7 and management of severe burns8); to attract substantial research funds from the National Health and Medical Research Council (NHMRC) and from the United Kingdom; and to implement data management programs they have designed. An important element of the success of the GMTT has been the process of peer review. A proposal that was generated within a specialty network did not progress unless it was supported by the medical, nursing and allied health peers within that network. Finally, to be adopted by the GMTT committee, the proposal had to be endorsed by peers from other specialties. This process added exceptional rigour to the resource allocation and ensured that it was not possible for specialists to make decisions that only benefited their own particular silo. For the future, is it better for a change agency such as the GMTT/GMCT to be inside or outside the tent? The GMTT was established as a ministerial advisory committee with regular and direct access to the Minister. This had the dual effect of energising the clinicians and alienating a sizeable section of the health bureaucracy. It created parallel processes — a circumstance that was considered necessary for change, but not viable in the long term. Following the Phelan review, it was agreed that the new GMCT should be integrated into the department, with dual reporting to the Director General and the Minister. This carries the opportunity for sustained influence, but the threat of demotivating some clinicians. Clinician vigilance will be required to ensure that the current genuine partnership with the bureaucracy is sustained. Time and achievements will tell. The next phase for the GMCT is challenging but exciting. Hospitals and their clinicians remain stressed by demands for services for which neither the dollars nor the available workforce are adequate. The GMCT must continue to expand its influence and reputation, develop further networks (orthopaedics, gastroenterology, respiratory medicine and urology are currently being targeted), and, most importantly, maintain the appropriate influence of clinicians on decision making. The challenge remains to ensure that the voices of those clinicians who are passionately committed to public hospital services are listened to as they should be. It has been a privilege to watch clinical colleagues respond so magnificently to the opportunities provided. This process for clinician governance merits recommendation to colleagues throughout Australia, where the benefits to patients and communities are likely to be the same. The Greater Metropolitan Transition Taskforce: achievements and outcomes For clinicians Involvement in making a difference for patients across greater metropolitan Sydney (five million people) Recognition of networks as peak advisory bodies for health service planning in their field Enhanced access for clinicians to Minister, Director General and Deputy Directors General of Health Dedicated infrastructure, including senior program manager and clinician-led data management Use of the networks for attracting research funds: Centres of Clinical Research Excellence, National Health and Medical Research Council (NHMRC) project grants, United Kingdom Medical Research Council trial funding Enhanced education and training, particularly for specialised nurses Enhanced communication and collegiality across professional and geographic boundaries For patients and communities Enhanced equity of access, particularly on the periphery of Sydney Greater equity of outcomes across the population Better clinical outcomes (eg, reduced morbidity and mortality [stroke network] and abolition of waiting times for living donor transplantation [renal network]) Representation on all clinical networks For government and Department of Health Better access to people who know where the solutions lie Safer, fairer and more cost-effective health care Assistance with identifying and addressing problems due to workforce shortages Details of the networks and their achievements can be viewed on http://www.health.nsw.gov.au/gmct.

Graeme J Stewart AM, PhD, FRACP, FRCPA · John M Dwyer AO, MB BS, PhD, FRACP · Kerry J Goulston AO, MB BS, MD, FRACP

The debate on its efficacy has been reignited Improvements in technology and greater acceptability have narrowed the gap between care in the hospital and care in the home. More patients with more diagnoses are receiving a greater diversity of hospital-type treatments at home than ever. However, the schism that once existed between hospital and home for treatment has opened up within the “hospital in the home” (HITH) movement over whether the concept works at all. In the early days, anecdotes suggested better outcomes at home, the only plausible mechanism being avoiding the risks of hospital. Then, it was easy to consider the high rate of adverse events in hospital and believe that HITH must reduce these. Because hospital-related adverse events are more common in older patients,1 it seemed plausible that older patients may have more to gain from HITH. However, the wide variety of adverse events hinted at difficulties in capturing the difference. It seemed even more obvious that replacing care in hospital with care at home must be cheaper. But critics thundered that HITH offered inferior care at greater cost.2 Both sides spoke without fear of contradiction because evidence was absent. But now there is evidence, and the debate has been reignited: Is HITH a true advance on in-hospital treatment with reduced complications, better health outcomes and greater patient satisfaction? Is it even cost-saving, or just a waste of money? On one side sits the Cochrane review, Hospital at home versus in-patient hospital care.3 This meta-analysis of 22 randomised controlled trials (RCTs) clearly concluded that there is no difference in outcomes and no cost savings! However, the review grudgingly accepts that patient satisfaction is greater with HITH than with hospital. The Cochrane process carefully sifted the trials to determine methodological rigour — whether the patients were adequately randomised, etc. Unfortunately, this sifting process did not include a criterion as to whether the basic experiment succeeded. One may assume that a review entitled Hospital at home versus in-patient hospital care would include only trials where patients in the control arm received their treatment in hospital, while those in the other arm received treatment entirely or almost entirely at home as a substitute for in-hospital care, with a curative intent. Studies of intensive palliative care at home should properly be called “hospice in the home”. Unfortunately, in one large study included in the Cochrane review, there was no statistically or clinically significant substitution for care in hospital by care at home. The study recruited older medical patients and the control group stayed in hospital 13.20 days while the group randomised to “HITH” was discharged 0.36 days earlier from hospital and then received an additional 9.04 days of “HITH” care at home.4 If the patients in the treatment group were not discharged from hospital earlier than the control group, that study does not meet the Cochrane review’s own definition of HITH, namely “treatment . . . that otherwise would require hospital in-patient care”, and should clearly have been excluded. Clouding by a study that did not meet HITH criteria was not the only impediment to discovering whether there was an improvement in health outcomes. Where outcomes were assessed, this was almost always done after discharge, often 3 or more months later. To be fair though, no one knew exactly what the difference in outcomes was, and so what “instrument” to use, at what time (during or after the admission) and how frequently to look for it, and in what patient group. On the other side, and providing the first inkling that there may be a difference, but that we had been looking at the wrong time, was an article published in this Journal. An RCT of 100 emergency department patients found a 20% decrease in the incidence of confusion in HITH.5 Three subsequent studies have now confirmed this. A trial (not an RCT) of surgical patients found less postoperative cognitive dysfunction at 7 days after day surgery compared with inpatient surgery.6 A United States multicentre trial (not an RCT) and an Australian single-centre RCT both showed significant decreases in delirium using the Confusion Assessment Method during the admission (to either hospital or HITH) for medical patients in HITH compared with hospitalised patients.7,8 The manifestation of this phenomenon in both medical and surgical patients demonstrates that the underlying diagnosis is not important, but the substitution of HITH care for in-hospital care is critical. Delirium is the “canary in the coalmine” of aged care — a transient early warning of increased mortality, nursing home placement and impaired physical and cognitive function. So, if delirium is reduced by HITH keeping patients out of hospital, you would expect to find reduced mortality and placement, and improved function, though a very large study or meta-analysis might be needed, because these events are less common than delirium. The Cochrane review, interestingly for a meta-analysis, does not combine all the data for mortality, and produces two solidly non-statistically significant results. But, if you combine all the Cochrane studies that measured mortality, excluding the palliative care studies (as Cochrane does) and the no-substitution study that should have been excluded, the odds ratio for mortality in HITH becomes a near-statistically significant 0.76 (95% CI 0.57–1.01; P = 0.0599)! The fact that it is not significant is probably a type II error. Interestingly, both groups in the Cochrane analysis, after removing the failed HITH trial, show an odds ratio of about 0.76 for mortality, indicating homogeneity. Even with borderline statistical significance, a one-quarter reduction in mortality from 17.8% to 13.4%, with a number needed to treat in HITH to prevent one death in 25, is clinically significant. Assessment for function in HITH studies shows two patterns. Studies where HITH substituted for hospital admission found that physical and cognitive function were improved.9,10 In studies in which patients are discharged early to HITH, the general focus on rehabilitation means that both groups attain comparable function. There are insufficient data on nursing home placement to draw conclusions. The problems with the financial analyses are similar, but simpler. Services where HITH is not a substitute for in-hospital care, but merely add-on care, are bound to be more expensive, no matter how sophisticated the economic analysis.4 Where HITH substitutes for in-hospital care, and the service works at reasonable capacity, HITH is cheaper than hospital.11 All the pieces are in place, though more evidence is needed to achieve statistical significance. The evidence clearly leads towards a conclusion that HITH offers better health outcomes and a reduction in costs.

Gideon A Caplan MB BS, FRACP

New Australian evaluation guidelines will help inform the debate It takes something like 10 years for a new compound to go from laboratory to clinical trial, and many more before a drug’s safety and efficacy are proven. Why isn’t clinical software — which might check for drug–drug interactions and dosage errors and generate alerts and recommendations to influence prescriber behaviour — treated as rigorously?1 Today, anybody with programming skill could create a rudimentary electronic prescribing package and put it directly onto the desktop of a general practitioner without regulatory approval. No doubt the stand-alone software in routine clinical use has undergone rigorous evaluation by its developers, but in most countries there is no specific regulation that requires this. Commercial vendors still sometimes sell prescribing systems with significant gaps in functionality.2 Some hospital prescribing systems are even sold devoid of the decision rules that will check for errors or guide prescribing. The expectation is that a hospital drug committee will have expertise in the development and maintenance of computational knowledge bases, an arcane and highly specialised skill set if there ever was one. Evidence mounts from systematic reviews that there is manifest benefit associated with clinical information technologies.3,4 However, case reports are appearing that indicate clinical software can sometimes cause harm.5 A new debate is building between those who demand that we rapidly introduce new information systems to improve the safety and quality of clinical practice and those whose view is that the evidence supporting its introduction is still wanting, and that, in some situations, there is a real possibility that it may do more harm than good.6 Much of the science on both sides in this debate is questionable. A widely reported article in 2005 identified 22 types of possible medication error risk associated with a clinical order-entry system.7 Clinical outcomes were not measured, and no attempt was made to explore whether these potential errors were the result of a badly designed system. Recently, Han et al reported that a hospital electronic prescribing system produced a statistically significant increase in mortality from about 3% to 7%.8 However, assigning the blame for this startling outcome solely to the software is problematic. Introduction of the software altered traditional work patterns and increased the complexity and time taken to prescribe. Yet the new system was implemented in less than a week — an extremely short time to introduce a complex new organisational process. On the technology proponents’ side, systematic reviews of decision support systems often try to infer which features are beneficial by lumping together widely dissimilar systems used in very different contexts.4 However, local and sociocultural variables strongly influence the uptake and efficacy of such systems,9 and these are rarely controlled for or quantified in studies, making it hard to interpret this type of systematic review. Further, citing lack of evidence for the value of different software features in a review, when the original studies were never designed to test for these features, does not say much. What should be done? The process guiding the development and testing of most medical treatments and biomedical instrumentation, including software embedded in or linked to clinical devices, is tightly regulated. In contrast, the development of stand-alone clinical software is not. In Australia, stand-alone decision-support computer programs, such as electronic prescribing systems, are not considered “therapeutic goods” and are not subject to regulation. Similarly, in the United States, software that relies on manual data input and that is not directly used in diagnosis or treatment is usually exempt from the premarket regulatory requirements of the Food and Drug Administration to demonstrate that the device is as safe and as effective as devices already on the market.10 Even if there were strict regulations for clinical software, defining either the process of system development or the knowledge within and behaviours of a system, there is no guarantee that software would be implemented or used safely. Information technology is only one component of health services.9 For the whole system to be safe, certification might have to include the skills of those using the software and the organisational processes within which the software is embedded. Consequently, the most appropriate model of governance over the safety and quality of clinical software is far from clear, and may involve elements of industry self-regulation, legislation and best practice guidance. These models are currently a matter of debate among organisations such as the International Organization for Standardization and the European Committee for Standardization. Locally, the National E-Health Transition Authority is developing basic technical standards for clinical software that should lead to more uniform and better engineered systems, and early work by the General Practice Computing Group examined the broader need for software accreditation. The United Kingdom’s National Programme for IT has moved further — establishing a safety team — and has embedded a safety management approach into its procurement processes. The Australian Health Information Council recently published national guidelines for the evaluation of electronic clinical decision support systems, to promote evaluation using rigorous and validated methodologies.11 The guidelines recognise that it is difficult to propose a single evaluation methodology that meets the diverse needs of both the software and clinical communities. Different user groups have different evaluation tasks and objectives. Even the choice of evaluation method is sometimes unclear, given the complexities of health services and the limited opportunities to carry out rigorously controlled trials. The guidelines outline approaches to testing the clinical effectiveness of decision support systems, their integration into existing work practices, user acceptability, and technical evaluations of the software and knowledge bases. Urgent debate is needed to move this agenda forward,12 and these guidelines should provide a platform to inform that debate. We can move quickly to develop appropriate models of governance for clinical software, or we can step back and let the courts decide, when legal cases of negligence occur. Some will argue that regulation inhibits innovation, but there are good examples of regulation driving technology innovation in other industries. The airline industry is often presented to us as a safety role model, but that industry was forced to change only after a string of catastrophic disasters. We can do much better by anticipating the potential risks of these technologies, rather than reacting to mishap. Over the next few years, despite people’s lives being saved or improved by these new systems, some hard lessons may be learned about their safe and effective use.

Enrico W Coiera MB BS, PhD · Johanna I Westbrook PhD, FACMI

Global warming is real, so what are we going to do about it, who will do it, and when? Climate change is now widely acknowledged as the greatest environmental threat that human civilisation faces.1 During 2005 there was a perceptible shift in scientific assessment of the consequences of increasing greenhouse gas accumulation in Earth’s atmosphere. Normally cautious climate scientists went on record with warnings that potentially unstoppable “runaway” climate change is now becoming a real risk. The faster than expected melting of Greenland ice, slowing of ocean currents, and possible reversal of terrestrial ecosystems (see Box) from carbon “sinks” to net sources of carbon dioxide emissions are prominent examples of non-linear change. Impacts of climate change on the biosphere are now clear, including melting of polar ice, shrinking of glaciers, and shifts in the biotic cycles and behaviours of birds, insects and plants. International assessments have sounded serious environmental alarms before, but the emerging evidence on climate change now brings an unprecedented urgency to policy debates. In the past year, public (and belatedly, political) discussion in Australia has moved on from questioning whether there is a human influence on climate change. The questions now being framed are what we should be doing about this, and who should be responsible? A 2°C limit to avoid dangerous climate changeLargely unchecked greenhouse gas emissions to date have already committed future societies to temperature increases. British Prime Minister, Tony Blair, commissioned a conference in Exeter in 2005 to answer the question “What level of greenhouse gases in the atmosphere is self-evidently too much?”.2 A limit in global mean surface temperature to 2°C above preindustrial times has since been recognised, in many ways, as a reasonably close marriage of pragmatism and science. Many small ecosystems in Australia are likely to be lost or severely damaged with temperature increases of 1–2°C (including the Great Barrier Reef, Kakadu, the Alpine zone, and the World Heritage rainforest area)3 as plants and animals are unable to adapt or migrate. Above 2°C, agricultural yields are predicted to fall, several billion people would experience increased water stress, additional hundreds of millions may go hungry, sea level rise may displace millions from coasts, and infectious disease risks multiply. Achieving a global average 2°C limit would result in slightly different temperature increases across Australia (lower than this in the south and greater warming towards the centre of the continent). Compared with the estimated future impacts of the current emissions trajectory, a 2°C limit would substantially reduce the annual heat-related mortality in Australia, as well as the southward extension of some mosquito-borne diseases.4 The immediate priority: reducing emissionsAchieving the widely proposed 2°C ceiling on global temperature increases means a rapid transition from fossil fuels to environmentally sound energy sources — within decades.5 Delays beyond that will necessitate far deeper and more rapid emission cuts to achieve this goal. The inertia of the socioeconomic system means that we cannot expect to be able to turn it around more quickly in future than we can now. Further, recent research by major Australian businesses (including BP Australia, Westpac, Insurance Australia Group, and Origin Energy) indicates there will be economic disadvantages if we delay. If early action is taken, a 60% reduction in Australian greenhouse gas emissions by 2050 is possible while still maintaining strong economic growth (with real gross domestic product [GDP] averaging 2.1% per year). Compared with this, postponing action to 2022 would result in lower real GDP growth of an average 0.2% per year, through to 2050.6,7 Climate change is a global problem that requires responses at multinational as well as national levels. The European Union plans to reduce its greenhouse gas emissions in line with a global 2°C target, and is investing in infrastructure, technologies and social policies. Sweden has announced a policy of non-reliance on oil by 2020.8 In contrast, climate change mitigation policy in Australia still lags behind Europe, and our government has not yet set a national greenhouse gas emissions reduction target beyond 2012. Procrastinating on reducing emissions means we are betting on future technological improvements to make the transition as seamless as possible. So far, there is no simple technological fix on the horizon to cure an overheating planet. The benefits of geosequestration (piping carbon dioxide emissions from power stations into storage wells), for example, have still to be proven in terms of efficacy, affordability and safety. It is far more likely that, as with preventive strategies for other major public health problems (such as smoking cessation or obesity reduction), we will need a “portfolio” approach to reducing emissions. While the full benefits from global greenhouse gas mitigation will only be experienced by future generations, the ancillary benefits of local emissions reduction policies would have immediate health benefits. For example, air pollution from motor vehicles caused an estimated 900–2000 early deaths in Australia in the year 2000, entailing direct costs of between $1.1 and $2.6 billion. A 50% reduction in vehicle-related emissions in the combined Sydney and Melbourne regions could avert 300–500 premature deaths per year from air pollution in those cities.4 Less car dependence (with a shift to public transport, walking and bike riding) would presumably also have substantial health and social benefits, through increased physical activity and social interaction. Adaptation measuresIt has been widely assumed that wealthy human societies will be able to buffer themselves from the more severe impacts of climate change, at least initially. However, events such as Hurricane Katrina and the European heatwave have shown that societies everywhere are vulnerable to extreme and unpredictable weather. In the late summer of 2003, an unprecedented heatwave in Northern Europe led to several tens of thousands of premature deaths.9 Elderly people were most vulnerable, as thermoregulatory ability usually decreases with age.10 The main contributing factor to this is reduced physical activity, leading to lower muscle strength, sweating capacity and cardiovascular reserve, and to lower cardiovascular stability. Drugs that affect body fluid balance, vasodilator activity and cardiac function are potentially harmful during extreme heat events. We know much more about the population-level risks that contribute to increased mortality during heatwaves. People in urban and suburban regions typically have far higher rates of mortality than rural regions. In France, many nursing homes were not air-conditioned, hospitals were understaffed, and families were holidaying (and hence unavailable to support elderly or mentally ill relatives) during what would usually have been a mild summer holiday period.11 Social isolation has also been linked to increased risk of death during heatwaves in the United States.12 The Australian Government has focused its policy development on identifying the risks and vulnerabilities of sectors to adapting to climate change.7 Health departments in several Australian states have commissioned studies of climate change adaptation needs: strategies, such as heatwave forecasting systems and associated directives for workplaces and nursing homes, and alerts for general practitioners, are now in the process of being developed. Details of adaptive strategies to reduce the impact of climate change will be local and context-dependent, although much can be generalised from experiences elsewhere. To support policy, we need more evidence about local conditions that modify heatwaves (such as the heat-island effect, household design to reduce heat retention, and social connectedness). We know that many bacteria (such as salmonellae) are sensitive to climatic conditions. It is less clear how the changing climate will interact with land use and social practices in a particular region to influence the vector, host (eg, domestic or native animal) and pathogen transmission routes for water-borne and food-borne diseases. We are beginning to understand the challenge that human-induced climate change poses for us, in terms of the likely impacts on humans. Anticipatory and precautionary adaptation is more effective and less costly than last-minute emergency adaptation or retrofitting.13 Even so, relying on incremental adaptation to lessen the evolving risks to health is as inappropriate as progressive multiplication of the number of defibrillator stations in a society undergoing an uptrend in coronary heart disease mortality. In the best traditions of public health, the focus must be on primary prevention — global greenhouse gas abatement. Individuals, families and communities should contribute to the collective effort, but the issue is so large in scale and so systemic in nature that only government-led mitigation can ensure that climate change is slowed and, hopefully, arrested. Glossary Ecosystem: A functional unit of interdependent organisms, together with their physical environment, linked together through nutrient cycling and energy flow. An ecosystem can be any size — a pond, field, forest, or Earth’s biosphere — but it always functions as a whole unit. Fossil fuels: Fuels such as coal, oil and gas made by the decomposition of ancient plant and animal remains which give off carbon dioxide when burned. Geosequestration: Sequestration is the storage of greenhouse gases from the atmosphere by plants or technological measures. Plants absorb carbon dioxide, release the oxygen and store the carbon in the soil. Geosequestration refers to the storage of carbon dioxide in underground reservoirs (such as old oil or gas wells). Greenhouse gases: Molecules (such as carbon dioxide and methane) that warm the atmosphere because they absorb some of the radiation that is emitted from the surface of Earth. Heat-island effect: Dark, dense materials (such as roof tiles or asphalt) absorb more heat from the sun than surrounding objects, and release the heat into houses and city areas in the evenings. In an urban heat island the temperature of a city can be 2–10°C higher than the surrounding rural area. The larger and more population-dense an urban area, the more pronounced is the heat-island effect. Landscape and housing design, vegetation, building spacing and paving materials all contribute to the heat-island effect.

Rosalie E Woodruff PhD, MPH · Anthony J McMichael FACOM, MB BS, PhD · Simon Hales MB BChir, MPH, PhD

The opportunity for informed choice in screening is limited Commencing in mid 2006, the Australian Government will phase in a national bowel cancer screening program for men and women who turn 55 or 65 years of age, and for those who participated in the government’s pilot screening program, conducted from November 2002 to June 2004.1 Eligible people will be invited to complete an immunochemical faecal occult blood test (FOBT) in the privacy of their own home and mail it in for analysis.2 Consumers will not be offered a choice of screening test. The government came to this position after commissioning a review of the costs, benefits and harms of different screening options3 and evaluating the pilot screening program.1 The study by The Multicentre Australian Colorectal-neoplasia Screening (MACS) Group in this issue of the Journal (A comparison of colorectal neoplasia screening tests: a multicentre community-based study of the impact of consumer choice)4 suggests that participation in screening does not differ significantly between different screening tests that might be offered. The implication is that consumer choice can be taken out of the equation if maximising participation is the primary objective of screening. If consumer choice does not influence participation, then why not offer a range of screening tests? This invites two prior questions — to what extent should the Australian Government be concerned about consumer choice and participation, and what criteria should be applied to determining screening options? For decades, Australia has accepted the World Health Organization guidelines for evaluating the worth of screening. These guidelines, recently updated, state “. . . in screening there is an ethical responsibility to conduct programs that will be of overall benefit to those who are screened and will minimize harm and anxiety that will arise. It is not simply the offering of medical tests for people to accept or reject as they wish. This responsibility implies that if evidence is not available from valid studies on the effectiveness of screening, screening should not be offered.”5 Although one in six participants in the MACS Group trial participated in a screening strategy other than FOBT,4 neither flexible sigmoidoscopy, computed tomography colonography nor colonoscopy meet the WHO criteria for a screening test. As yet, there is no trial evidence that any of these tests reaches an acceptable ratio of population benefits to harms and costs that would warrant their inclusion in a national screening program. The results of the MACS Group trial raise important questions about whether participation in screening is an appropriate measure of success and whether participation itself is an adequate measure of consumer choice. The traditional view, one shared by the updated WHO guidelines, is that participation is a measure of success.5 All things being equal, the more people who are screened, the greater the reduction in bowel cancer mortality in the population. That line of reasoning is incontestable. What is contestable is whether people who participate in screening make an informed choice. The MACS Group suggest that the one reason why their participation rates (averaging 20.9% over all screen tests) were lower than the government pilot projects (45.4%)1 and other international programs is that the Group were required to “present the invitation as a clinical research project with due informed consent” (our emphasis). This, argues the MACS Group, may have contributed to a lower participation rate. They then suggest that a “guided choice” following formal clinical review might improve participation. The Australian Government should seriously consider providing a decision-support system that allows consumers to decide whether they want to take up the offer of screening, based on information of benefits, harms and the process of testing. This should include a guide to screening options. Not everyone will want or need a “guided choice”. Our previous study of consumer choice of FOBT screening found that a third of the target group opted for screening no matter what the ratio of harms to benefits, 55% took up the offer of a guided choice (weighing up the benefits and harms), and 12% chose outright not to be screened.6 Even if 30% of the target screening group take up the offer of a guided choice by a general practitioner, based on the 75% Medicare rebate for a level-B GP consultation, the cost per life-year saved (LYS) of biennial FOBT screening without a routine GP consultation would increase from about $13 5007 to $21 000 per LYS. If 70% of the target population opt for a GP visit, the cost per LYS is $31 300 — more than double the cost effectiveness ratio for a screening program without a routine visit to the GP. Even so, this figure is comparable to other cancer screening programs. The challenge is to develop an affordable decision-support system — one that is either self-directed or one that offers restricted access to an additional GP consultation. This applies equally to those aged under 55 years who will not be eligible for screening in the national program. Unless the national program actively engages the community, GPs and pharmacists in screening and diagnostic assessment of people with a positive FOBT, the opportunity for an informed choice and participation is limited. A key question for the National Bowel Cancer Screening Program is whether setting participation targets and using them to measure the success of screening is appropriate. Falling short of a 70% target participation rate shouldn’t be taken as a public health failure if it can be shown that consumers have had an opportunity to make an informed choice (alone or with their GP), using a decision-support system if they wish to do so. Informed consumers making smart choices about screening — now that would be a public health success.

Glenn P Salkeld GradDipHealthEcon, MPH, PhD · Jane M Young MPH, PhD, FAFPHM · Michael J Solomon MB BCh, MSc, FRACS

Guidelines for GPs need to tackle the tough issues These are interesting times in Australian mental health. On a daily basis, the gap between best practice guidelines and the quality of services delivered widens. Rapid advances in clinical neurosciences give us real enthusiasm for new approaches to treatment. By contrast, national and state-based inquiries highlight fundamental failures in acute and ongoing care. Although major service redevelopments continue, we do not yet provide an integrated health services response. All our governments now concede that a new round of investment, innovation and coordinated reform is essential. Substantial new investments are justified and necessary if we are to see genuine innovation, improved access to care, and better health outcomes in the mental health service environment. The production of guidelines for bipolar disorder internationally reflects the therapeutic gains that should be available for people with this common and disabling illness.1,2 However, when guidelines target general practitioners, like the recommendations provided by Mitchell et al in this issue of the Journal (The management of bipolar disorder in general practice),3 some hard questions need to be asked. Are they relevant to general practice in Australia? Do they connect with the target audience? Are the recommendations achievable in our health care environment? In recent years, most GPs feel that they have received truck loads of worthy guidelines from their specialist colleagues. Although guidelines are critical to improving health care quality, in the end most fail to recommend strategies that lead to real impacts on clinical practice. The mental health field is no exception. It too is awash with new guidelines.4 Surprisingly, given that 75% of mental health consultations take place in the primary care environment, few have targeted general practice. A notable exception is the guidelines for the treatment of depression in general practice settings, commissioned by beyondblue: the national depression initiative.5 From a GP’s perspective, most mental health guidelines don’t concede basic service limitations. First, GPs are not an unlimited mental health resource. In fact, recent data indicate a major slowing in the rate of increase in the treatment of common mental disorders in primary care settings.6 Second, mental health guidelines compete with all other medical guidelines for attention. Simply producing more guidelines for more disorders doesn’t increase the likelihood that recommendations will be put into action. Producing more guidelines for closely related topics (eg, bipolar depression,3 major depression in specialist settings,7 major depression in primary care,5 youth depression8) also doesn’t help. Third, simply extrapolating evidence from studies conducted in patients with severe, chronic or complex disorders encountered in specialist treatment centres may not only be scientifically questionable, but may particularly annoy GPs.9 Most importantly, “GP guidelines” for mental disorders should deal explicitly with the key issues: identification of less severe forms of the disorder; management of medical comorbidity; overlap with alcohol and substance misuse; limited geographical and economic access to specialist psychological support; use of alternative treatments for less severe or less complex cases; and implications of poor access to specialist assessment during acute phases of illness. Providing a detailed list of reasons for specialist referral does not assist those GPs who struggle on a daily basis to connect with any specialist support in the private or public sector. Rather than addressing such issues, specialist psychiatry has a particular knack for creating more disorders, more subcategories and more complex treatment regimens.1-3 The self-explanatory nature of manic-depressive illness has been replaced by the more opaque terms “bipolar I”, “bipolar II”, “bipolar depression”, “mixed episodes”, “rapid cycling”, and “cyclothymia”. However, if such fine-grained differentiation is not associated with quite specific differences in treatment or prognosis, or is not based on a solid evidence base,10 then it holds little appeal. The medical, psychosocial and legal consequences of a GP making a diagnosis of bipolar disorder are potentially considerable. To suggest that these can be minimised by having all such decisions reviewed by a specialist is highly optimistic, especially given the decreasing availability and inequitable access to such resources. While recent improved access to psychological therapies through partnerships in general practice,11 and proposed direct referral mechanisms to clinical psychologists,12 are most welcome, it is not yet clear whether these developments will increase access for patients with bipolar disorder to the more intensive and targeted therapies they require. From a primary care perspective, the most useful mental health guidelines tackle the tough issues that cross a GP’s desk on a daily basis.9 Where are the best sources of self-help, self-monitoring, detailed illness descriptions, and family education to be found? Are there high quality e-health resources available?13 What options are available to a GP when patients become a danger to themselves or their reputations? How should a GP deal with poor compliance? What are the cost implications for patients of particular management plans (eg, costs of travel to specialist appointments)? What should the GP do when specialist services are not available? What are a GP’s responsibilities when the patient doesn’t return for follow-up appointments and/or medication monitoring? How should a GP document mental health consultations in their medical records? What other clinical or management resources are available? Is additional training required to deliver the therapies recommended in the guidelines? While the recommendations presented by Mitchell et al,3 and the related technical summaries, do provide useful clues, insufficient attention to these practice-based issues risks an overall negative rating from the target audience.

Ian B Hickie MD FRANZCP · Grant A Blashki MD, FRACGP

A clash of purpose between a journal’s editors and its owner 20 February 2006 may well be the day that marked the beginning of the decline of the CMAJ (Canadian Medical Association Journal) as a widely respected national and international journal. On that day John Hoey, Editor-in-Chief of the CMAJ for 10 years, and his Deputy Editor Anne Marie Todkill were summarily dismissed by Graham Morris, the president of CMA Media Inc which publishes the CMAJ.1 As to the reasons for the firings, Morris said, “I felt that after 10 years it was time for a fresh approach.”2 His rationale was greeted with disbelief and derision from leaders in the publishing field. Frank Davidoff, Editor Emeritus of the Annals of Internal Medicine was reported as saying, “Oh, come on! A summary firing without a cause? I mean, how naïve do they think people are?”, adding, “I think it could be the death knell of this Journal”.3 The dismissal of Hoey and Todkill provoked editorial comments in the Lancet4 and the British Medical Journal (BMJ),5 and condemnations from the Council of Science Editors, the World Association of Medical Editors and the International Committee of Medical Journal Editors — all parties called for the Canadian Medical Association (CMA) to respect editorial independence.4 Within 3 weeks, the CMAJ was reduced to a shell of its former self. The journal’s Acting Editor-in-Chief, Stephen Choi, resigned, along with its Editorial Fellow and a number of Associate Editors. Their resignations were provoked by the failure of the CMA to agree to Choi’s request that the publisher and the owner of the journal, CMA Holdings, a commercial subsidiary of the CMA, not interfere with editorial content.6 In dire straits, the CMA turned to Bruce Squires, the previous Editor-in-Chief, to resume this role in an acting capacity. Seventy-one-year-old Squires declined and urged the CMA to heed Choi’s request for editorial independence. Finally, 16 of the 19 members of the CMAJ editorial board resigned.6,7 There was dismay and disquiet in the Canadian medical community. Anger among academics, researchers and clinicians followed, with calls for a boycott of submissions to the CMAJ and the activation of a worldwide petition for editorial autonomy at the CMAJ, and the reinstatement of Hoey and Todkill. There was even talk of setting up an open-access journal in competition with the CMAJ.7,8 Caught in this imbroglio, the CMA desperately needed a circuit breaker. This came with two announcements. The first announced yet another Acting Editor, Noni MacDonald (a former Dean of Medicine), the assembly of a new editorial board, and the release by the CMA of nine interim principles for editorial governance, including editorial independence.9,10 The second was more striking, announcing the formation of a panel of eminent authorities to “review the Canadian Medical Association Journal’s (CMAJ) governance structure and to provide objective recommendations to further the CMAJ’s continued commitment to editorial independence and maintaining excellence in reporting on the science and art of medicine.”11 The review panel, chaired by Antonio Lamer, a former Chief Justice of the Canadian Supreme Court, is to report soon. Despite these measures, dissatisfaction remains. It is obvious the current turmoil was driven by matters other than the desire to seek new directions.2 What then was behind the sacking of Hoey and Todkill? During Hoey’s tenure, there were smouldering tensions between the CMAJ and CMA as to who should have control over the journal’s content, particularly if this was politically or commercially awkward for the CMA.6,7 These tensions reached a climax in the months immediately before the sackings, with two CMAJ news items — the Plan B story (a CMAJ investigation of over-the-counter dispensing of the newly approved emergency contraceptive pill by Canadian pharmacists) and the Tony Clement story (an article commenting on his appointment as Minister of Health in the Conservative Canadian Government, which was critical of his stance on privatisation of health services).12 In late 2005, reporters from the CMAJ began an investigation into the circumstances surrounding over-the-counter dispensing of the emergency contraceptive pill — the investigation became know as the Plan B story. They asked 13 women to purchase the pill and report the conditions for its procurement. They found that the women had been asked private and personal questions by pharmacists, in accordance with the guidelines of the Canadian Pharmacists Association (CPhA). On learning of the investigation, the CPhA complained to the CMA that the exercise was not investigative journalism, but research, and thus should have had ethical approval. They also objected to what they considered to be covert observation of pharmacists. Hoey was instructed by CMA executives to pull the article; he did not, but when it appeared, details of the personal questions had been expunged. This was tantamount to censorship. After complaints by privacy commissioners following the publication of the story, the CPhA instructed its members to desist from extracting private information from consumers. However, the damage to CMAJ editorial independence had been done. This blatant breach was publicly exposed in a CMAJ editorial in December 2005, which noted that, “As a serious vehicle for science, news and opinion, CMAJ cannot avoid the discussion of contentious issues. It is not unexpected for tensions to arise between the association and the journal from time to time, for our mandates are not the same.”13 To bring the matter to a head, Hoey asked an ad hoc committee of the editorial board to review matters related to the handling of the Plan B story. During its deliberations, the committee’s attention was drawn to further instances of tampering with another news item — the Tony Clement story. This article, which was critical of Clement’s stance on privatisation of health services, was published electronically on 7 February 2006, but was subsequently removed from the website. It reappeared on 22 February 2006 as a different report, less critical of the Minister and more in harmony with the CMA stance on privatisation. The full texts of both versions are detailed in the final report of the ad hoc committee, chaired by Jerome Kassirer, the previous Editor-in-Chief of the New England Journal of Medicine, and with high-level individuals in medical publishing, journalism and academic medicine as members.12 After duly examining all relevant issues, the committee dismissed the complaints of the CPhA and reaffirmed the legitimacy of responsible journalism as an integral part of modern medical journals, drawing attention to this practice in the Lancet, BMJ, Science, Nature and the Journal of the American Medical Association. Significantly, it suggested that the CMA and CMA Holdings had a decision to make: either support editorial independence or run the risk of the CMAJ degenerating into “an association rag.” The committee also noted that, “Despite claims by the CMA, . . . the editorial autonomy [of the CMAJ] is to an important degree illusory” and that “Publishers have the option of dismissing an editor who exhibits a pattern of incompetence, misconduct or fiscal irresponsibility. As long as editors hold their position, however, they must be free to make editorial decisions independently of the ideological, strategic or commercial interests of the publisher. The editor’s conduct should be judged against the ideals of the medical profession and against standards of accuracy, precision and fairness. Editorial decisions should not be judged against the particular aims of the CMA.”12 In this context, the CMA President, Ruth Collins–Nakai, more recently revealed that “irreconcilable differences” between the editors and the publisher of the CMAJ were the real reasons for the sacking of Hoey and Todkill.14 Publishers and editors worldwide now await with interest the findings of the Lamer panel. Meanwhile, what can we learn from the CMAJ crisis? Editorial independence will only work if there is a clear understanding between owners and editors of journals as to a journal’s mission, and the empowerment of an editor or groups of editors to implement this mission and to be responsible for the cover-to-cover content of the journal. Essential to this process is the trust that editors will realise the stated ideals by making sound decisions and, at the same time, enjoy the freedom to publish controversial material, even when this is at odds with the purpose, politics and practices of the body owning the journal. In short, editorial independence is built on mutual respect, open communication and a clear understanding of boundaries.15 These appear to have been in short supply in the Hoey affair.

Martin B Van Der Weyden MD, FRACP, FRCPA

Solutions for Indigenous health problems may hold the key to solving those of other disadvantaged groups in our society There is a substantial and chronic shortage in the health care workforce for Indigenous Australians.1 Of the many factors that contribute to this, one is the lack of suitably trained and willing doctors. In the past 25 years, there have been major efforts to improve medical education to address this problem. As shown by Paul et al in this issue of the Journal 2 and others,3,4 medical schools have slowly changed their curricula to include material specific to Indigenous health, several Australian medical schools have introduced recruitment and support programs for Indigenous and rural students and, more recently, clinical colleges and other medical organisations have promoted cultural awareness activities.5,6 These initiatives rely largely on providing information to a (presumably receptive) profession, based on the underlying premise that most Australian doctors are not aware of the cultural mores and the socioeconomic and health problems of Aboriginal and Torres Strait Islander peoples. It seems to be assumed that informing them will be enough to change their attitudes and behaviours, and that this will improve access to health care for Indigenous Australians. However, despite these and many other initiatives, as several articles in this issue of the Journal (Hayman et al,7 Zhao and Dempsey,8 Ho et al,9 and Harrington et al10) indicate, lack of timely access to quality medical care continues to be a major problem. The ongoing inertia suggests that despite current educational efforts, the medical profession may still have poorly conceived attitudes and beliefs about Indigenous peoples’ health that are unrelated to the realities of Indigenous life, and an impediment to overcoming the workforce shortages. Three separate but related issues — competing priorities, victim-blaming and individualism — stand out. We all prioritise information. As we know from our attempts to help patients change unhealthy lifestyle practices, raising awareness is only a part of what is needed to change behaviour. Few smokers believe that smoking is healthy but, for many, smoking cessation is not at the top of the list of their personal priorities, as they have other pressing issues which seem much more acute than dealing with nicotine addiction.11 It may be that Indigenous health is just not high on the list of many doctors’ priorities. Victim-blaming is still prevalent in community attitudes,12 and may also be reflected in the beliefs of some doctors.13 Why should doctors, whose central focus is to alleviate suffering, harbour attitudes that are less than helpful for marginalised and disenfranchised Australians? A paradoxical explanation may be our reverence for those who overcome adversity. Since the Enlightenment, people of European descent have been enthralled with the concept of struggle. This is demonstrated in Australian political campaigns, in which all the candidates vie for underdog status. Two sentinel publications that irrevocably changed the 20th century focused on struggle — Darwin’s The Origin of Species (1859; struggle for life) and Marx and Engel’s tract The Communist Manifesto (1848, struggle of classes). In our modern age of plenty, we seem to have a deep-seated need to have our own struggles acknowledged. Unfortunately, many of those who have struggled successfully show disdain for those who have, in their judgement, not struggled hard enough to overcome adversity. Another societal attitude that may find expression among medical professionals and diminish their interest in Indigenous Australians is individualism. The more we progress and the more individualistic we become, the less we show concern for those who are most unlike “us” (see McDermott14). Recently, in Queensland, an Aboriginal Elder who had a stroke at a bus stop outside the tertiary institution at which she is an “Elder-In-Residence” was left to suffer on the footpath by other Australians.15 Ironically, the people who eventually stopped to help her were Japanese students. In their own “otherness”, the foreign students were unencumbered by the prejudices and racial stereotypes that afflicted the many other bypassers. Can we continue to perceive the problems of Indigenous Australians with dispassionate disinterest? The causes of Indigenous morbidity and mortality are now dominated by non-communicable chronic diseases (see Zhao and Dempsey8), such as diabetes and heart disease; these conditions are also the major causes of morbidity and mortality in the non-Indigenous population. It is possible that if health professionals work with Indigenous communities to find solutions for chronic disease in Indigenous populations, they will be repaid with solutions for epidemics of the same diseases among non-Indigenous Australians. This point was made last year in a keynote address by Professor John Hamilton (former Dean of Newcastle medical school in New South Wales) to the Towards Unity For Health conference in Vietnam. He recalled a public statement made by our first author (L G P), that if non-Indigenous Australians would walk with Indigenous Australians to find solutions for the health problems of Indigenous people, their gift in return will be a better understanding of non-Indigenous people who are marginalised and disenfranchised. Professor Hamilton later bore witness to this phenomenon when he was able to apply the lessons he had learned from the recruitment program for Indigenous Australians at the Newcastle medical school to the creation of a new medical school in his native England, which needed a program to reach out to a group of disadvantaged young people. We can look on the terrible state of Indigenous health in Australia, and see a burden for health care, or we can see an opportunity. We know that simple and relatively inexpensive measures in Indigenous health can make substantial differences.16 In many Indigenous communities, grandparents are the primary carers for young children. An extra 5 years of life for a “nanna” can mean that these children do not have to lose the single most important adult figure in their life during the vulnerable adolescent years; this would translate into many more years of health for future generations. As a profession, we are confronted with an opportunity to give Indigenous health priority, upskill ourselves with appropriate cultural and clinical training, cease to blame the victims, and acknowledge that “their” health problems are actually “our” problems. We can loose the bonds of individualism and recover an understanding of what it means to live in a community. The state of Indigenous health ought to matter to all Australians, and it should be regarded as an opportunity rather than a burden. Let us not miss the opportunity.

Louis G Peachey BMed, FACRRM · Kristin E McBain BSocSc(Hons) · Ruth M Armstrong BMed

Accessible and culturally appropriate services are needed The National Heart Foundation of Australia and the World Health Organization recommend that all patients with cardiovascular disease are routinely referred to an appropriate cardiac rehabilitation program.1,2 Their recommendations are based on firm evidence that three-phase rehabilitation programs — inpatient, outpatient and maintenance — provide a range of short-term and long-term benefits to health and wellbeing. Key points for success Ensure that cultural competency is integral to the core business of an organisation and supported at all levels within the organisation (eg, employ Indigenous staff across the organisation, support cultural awareness training for non-Indigenous staff, ensure availability of and support for interpreters and cultural mentors). Involve Aboriginal health workers and family members in the care of Aboriginal and Torres Strait Islander patients and develop flexible approaches to raising awareness of the importance of cardiac rehabilitation. Ensure community involvement in planning, implementing and evaluating health promotion, including the development of culturally appropriate materials. Incorporate elements of cardiac rehabilitation and secondary prevention into existing activities or set up activities that draw on existing networks within the community. Develop and sustain partnerships between organisations (eg, a hospital providing outreach cardiac rehabilitation services through the local Aboriginal Community Controlled Health Service). Take the specific needs of Aboriginal and Torres Strait Islander patients into consideration in planning and delivering mainstream cardiac services and develop policies and procedures to address these needs (eg, identifying Aboriginal or Torres Strait Islander status, providing culturally appropriate information on hospital discharge). Develop a specialist education base for continuing training and support of all health professionals working in cardiac care, including Aboriginal health workers. Although the benefits of cardiac rehabilitation are clear, only a small proportion of the people in the general population who have experienced cardiac events attend programs.3 Aboriginal and Torres Strait Islander people are even less likely to participate in cardiac rehabilitation programs than non-Indigenous Australians,3-5 despite being twice as likely to die from cardiovascular disease.6 As there is little published literature specific to cardiac rehabilitation among Aboriginal and Torres Strait Islander peoples, the National Health and Medical Research Council convened a committee to investigate barriers to effective practice and develop guidance for health professionals working in the area. In November and December 2004, the committee conducted workshops, hosted by Aboriginal Community Controlled Health Services in Darwin, Townsville and Mt Druitt (Sydney). Indigenous health professionals and consumers were asked to share their stories and make suggestions about how cardiac rehabilitation services could be made more accessible. This information contributed to the development of a practical guide for health professionals — Strengthening cardiac rehabilitation and secondary prevention for Aboriginal and Torres Strait Islander peoples: a guide for health professionals.7 The guide was tested for suitability by potential users of the manual at a workshop held in Adelaide in June 2005 and was published in September 2005. Through the workshops, the following barriers to uptake of cardiac rehabilitation among Aboriginal and Torres Strait Islander people were identified. “Not enough black faces”: Aboriginal and Torres Strait Islander people are not sufficiently involved in planning, delivering and evaluating relevant health care services. Contributing to this is a lack of training, education and support for Aboriginal health workers. Communication and understanding: Cultural factors that are often not understood and therefore not taken into account in mainstream services include the diversity of Aboriginal and Torres Strait Islander peoples and culture; the complexity of Aboriginal law; the importance of family and community involvement; and a holistic view of health that includes the body, the land and spirituality. Continuity of care: The process of cardiac care usually involves many different settings and people. Lack of continuity and linkages between services, in particular between mainstream and Aboriginal and Torres Strait Islander services, mean that people can miss out on important aspects of care. This is made worse when people live in remote communities and have to travel long distances to access services. Taking the message back home: It can be difficult to maintain a healthy lifestyle back in the community, where adopting healthy behaviours may be less of a priority than meeting basic needs such as food and housing, expectations of health may be low, and there may be strong counteracting social pressures. Self-determination and control: Health intervention programs may be implemented without appropriate consultation and community involvement from the outset. Programs are unlikely to succeed unless they build on the leadership provided by the community and on real partnership with the local community. Addressing these barriers presents considerable challenges. No single solution can be applied, due to the diversity within the population, as well as the need to find approaches that are suitable to remote, rural and urban areas and that take into account cultural issues and staff availability. Multidisciplinary methods are therefore required2 that can be adapted to make use of the skills available in each setting while taking a standardised approach to supporting system change. The Indigenous health sector and Indigenous health professionals are best placed to provide cardiac rehabilitation to Aboriginal and Torres Strait Islander people and should be supported to do this. However, cardiac rehabilitation is more likely to comprise a combination of both Indigenous and mainstream services (ideally a team including an Aboriginal health worker and general practitioner, with other health professionals as required). Establishing and maintaining links between individuals and organisations involved in cardiac rehabilitation is therefore fundamental to improving outcomes. Such linkages support continuity and quality of care, broaden the capacity of the health organisation, increase access to resources and help to integrate mainstream and Indigenous health services, so that it is easier for patients to move between the two systems. At the centre of care are the patients themselves. Showing cultural respect, as well as learning from patients and their families, carers and the community, will increase understanding of how culturally competent health care can best be provided.8 For example, addressing chronic diseases together in an holistic way is more consistent with Aboriginal and Torres Strait Islander concepts of health and illness than considering single diseases or body parts. This approach can also better take into account the importance of spirituality to health and wellbeing, depression and other psychosocial factors increasing the risk of cardiovascular disease,9 and the cultural, environmental and historical risk conditions that place Aboriginal and Torres Strait Islander people at greater risk of the onset and complications of chronic diseases. There is considerable activity under way across Australia to improve the cardiovascular health of Aboriginal and Torres Strait Islander peoples. Systems are in place to assist health services to improve preventive and coordinated care for these patients10 and there is a growing knowledge base to support improved practice. However, continuing efforts are needed across all health care settings, at both individual and organisational levels, to implement sustainable changes that will ensure that appropriate cardiac rehabilitation services are available for Aboriginal and Torres Strait Islander Australians.

Noel E Hayman MB BS, MPH, FAFPHM · Mark Wenitong MB BS · Jenny A Zangger BA, DipApplSci · Elizabeth M Hall BSc

New guidelines and funding for this preventable disease have been long awaited In line with its Vision 2020 initiative, the World Health Organization adopted a resolution to eliminate blinding trachoma by 2020. To achieve this goal, WHO recommends the SAFE strategy (Surgery, Antibiotics, Facial cleanliness and Environmental improvement) for countries implementing trachoma control programs. Australia is the only developed country of the 57 trachoma endemic countries listed by WHO.1 Trachoma was endemic and a significant cause of blindness in many parts of the Western world, including Australia, until the early 1900s. As housing, hygiene and living conditions improved, trachoma disappeared from most parts of Australia.2 However, these improvements are yet to occur in remote Aboriginal populations in Australia, where trachoma is still endemic. Why is Australia the only developed country with endemic trachoma? Firstly, the socioeconomic determinants of trachoma (ie, poverty and overcrowded living conditions) are highly prevalent among Aboriginal people living in remote areas. Secondly, Australia’s trachoma control efforts have been patchy and inconsistent since the National Trachoma and Eye Health Program finished in 1978.3 In the absence of a national approach, some trachoma-endemic states or areas have prioritised trachoma control and have implemented programs based on the 1993 WHO trachoma control guidelines, while others have not. Furthermore, while all current programs include periodic trachoma screening and antibiotic treatment, very few include the “S”, “F” and “E” components. Thirdly, epidemiological data on trachoma, an essential element of any control program, are difficult to obtain and interpret because each trachoma control program has its own data collection system, and data from different regions and states are not collated. Trachoma is not a nationally notifiable disease. Thus, despite availability of a highly effective one-dose treatment (azithromycin) provided free through remote Indigenous health clinics and regional population health units since 1998, trachoma transmission continues. Recent molecular epidemiological research from the Northern Territory showed different Chlamydia trachomatis strains in coastal compared with inland communities, indicating that trachoma transmission may occur more within communities or within groups of neighbouring communities rather than between far-flung, distant communities.4 In contrast, a similar Western Australian study showed that most WA trachoma strains were of the Ba Apache type, which circulated in both coastal and central communities across the length and breadth of WA and was identical to one of the NT strains.5 This finding is consistent with anecdotal reports of high levels of mobility of Indigenous people within and between regions, and suggests that the effectiveness of trachoma control activities may be improved by enhanced inter-regional coordination (eg, conducting trachoma screening and treatment at the same time in all affected areas). Key recommendations of the Guidelines for the public health management of trachoma in Australia6 Trachoma control should be the responsibility of government-run regional population health units, working in collaboration with primary health care services and Aboriginal community representatives. Regional population health units should collect trachoma data in accordance with the minimum national trachoma dataset. Surgery In regions where trachoma is endemic but trichiasis prevalence is unknown, the burden of trichiasis should be quantified. In areas where trachoma or trichiasis is or has been endemic, Aboriginal and Torres Strait Islander people aged 40–54 years should be screened every 2 years and those aged 55 years and older should be screened annually for trichiasis as part of an adult health check. Antibiotics The minimum target group for active trachoma screening should be Indigenous children aged 5–9 years living in communities/towns where trachoma is endemic. All children found to have active trachoma and their household contacts aged 6 months and older should be treated with single-dose azithromycin. Antibiotic treatment of affected people, household contacts and community members (when required) should be completed within 2 weeks of screening. Where population mobility is high, all screening and treatment activities within the region should be completed in as short a timeframe as possible to minimise the likelihood of reinfection and to achieve higher population coverage. Facial cleanliness Facial cleanliness in children should be promoted by including regular face-washing as part of a holistic personal hygiene program. Environmental health Environmental health, school and health promotion staff should be involved as key stakeholders when regional population health units and primary health care services plan and implement trachoma control activities so that “F” (Facial cleanliness) and “E” (Environmental health) strategies appropriate to individual communities/regions can be implemented. The publication of the Guidelines for the public health management of trachoma in Australia,6 which were developed by the Department of Health and Ageing and the Communicable Diseases Network of Australia (CDNA), and the Australian Government’s allocation of $920 000 towards trachoma control over the next 3 years7 represent a long-awaited national approach to controlling this preventable disease. The states and territories will receive $470 000 of this new funding, to train health workers to implement consistent trachoma screening and control measures. The remaining $450 000 will be used to establish a national trachoma surveillance unit to enable consistent data collection on trachoma. The CDNA’s trachoma steering group, which has representatives from states and territories where trachoma is endemic, will provide expert advice regarding trachoma surveillance and control. The guidelines cover trachoma screening, control and data collection (Box). They recommend that trachoma control, including data collection and reporting, should be the responsibility of, and coordinated by, government-run regional population health units, working in collaboration with primary health care services and Aboriginal community representatives. The guidelines stress the importance of implementing all four components of the SAFE strategy. In accordance with one of the resolutions of the 2003 Global Scientific Meeting on Trachoma, the guidelines recommend single-dose azithromycin for all children and all adult household contacts of affected people when childhood active trachoma prevalence is 10% or greater.8 Monitoring of azithromycin resistance is recommended.9 The guidelines are consistent with the spirit of, but do not replicate, the WHO guidelines because high level evidence from randomised controlled trials or meta-analyses of randomised controlled trials exists only for one component (Surgery) of the WHO’s SAFE strategy, and because it is considered important that Australian guidelines reflect Australian experiences of trachoma control.10 Not all stakeholders may agree with the recommendations. Some may dispute the need, given the magnitude of death and ill health in Aboriginal communities due to diabetes, heart disease, mental illness and injury, to channel health resources towards a condition that they believe rarely or no longer results in blindness.11 Others may consider the guidelines too conservative to be able to eliminate blinding trachoma by 2020. Despite these criticisms, the guidelines will at least establish, for the first time, a national minimum best-practice approach for the public health management of trachoma, which if implemented can only strengthen Australia’s efforts towards controlling and eliminating trachoma. Furthermore, they provide yet more impetus for further and broader initiatives to address socioeconomic deprivation, the underlying cause of continued trachoma transmission in Australian Aboriginal communities.

Donna B Mak MB BS, MPH, FACRRM, FAFPHM

A collaborative trial is needed At a time when there is a widely held perception that older people, and particularly nursing home residents, are occupying acute care hospital beds at the expense of others,1 the article by Finn et al2 in this issue of the Journal is very pertinent. It describes the presentation, over a 6-month period, of a cohort of 541 patients from aged care facilities (nursing homes and hostels) to the emergency department of a large tertiary hospital, and notes that the substantial majority (87%) of these presentations were considered to be appropriate. These patients were acutely unwell (most having been so for less than 2 days) and required the investigations and expertise available in the emergency department for diagnosis and management. Sixty per cent of these patients required hospital admission and most (90%) survived to be discharged back to their aged care facility. There are currently about 78 000 people in nursing homes across Australia and about 81 000 in hostel care.3 These numbers will continue to grow as the number of older people increases. Consequently, presentations to emergency departments and admissions to hospital are also likely to increase, placing further strain on already busy hospitals. Hospitals can be dangerous and unfriendly places for frail older people or people with dementia, who are most likely to be residents of aged care facilities. Polypharmacy, undernutrition, skin tears, pressure areas, fall-related injuries, nosocomial infections, and deconditioning are some of the hazards of hospitalisation.4 It is therefore now very appropriate to be looking at methods of reducing the need to hospitalise these patients by providing assessment and management of selected conditions within aged care facilities. Finn et al suggest some of the resources that would be required to prevent inappropriate hospital presentation (such as the ability to insert indwelling catheters and to replace percutaneous endoscopic gastrostomy tubes), but more than this will probably be necessary. Recently, a number of hospitals around Australia have identified the need to work more closely with aged care facilities and general practitioners to provide acute care to patients in nursing homes. For example, Gold Coast Hospital in Queensland has piloted a “Hospital in the Nursing Home” program that delivers acute care to nursing home residents using their own GP and nursing home staff, with medical and nursing input from Gold Coast Hospital staff.5 This service also provides education and information to nursing home staff in areas such as wound care, continence management and intravenous fluid administration, enabling staff to improve their skills in these areas. Clinical pathways are used for management of pneumonia, urinary sepsis, dehydration, palliative care and wounds. The service has treated 400 patients, resulting in hospital bed-day savings of more than 1500 days over 2 years and allowing residents to stay in familiar surroundings while receiving acute care (Ms Kerry Robinson, Project Officer, Aged Care Early Intervention and Management, Gold Coast Hospital, personal communication). This would appear to be a positive outcome for all parties, but a randomised controlled trial would be needed to confirm the effectiveness of the intervention. Finn and colleagues also raise a number of other issues that merit attention, and addressing these issues could potentially avoid some presentations and improve information sharing in others. Their study revealed that a GP had been consulted for only a quarter of patients presenting to the emergency department. Increased GP availability and involvement is clearly important, given that 126 out of the 136 presentations involving GP input were judged “appropriate”, whereas up to 45 of the 71 presentations considered “inappropriate” could have been avoided if GP review had occurred. With the increased use of Enhanced Primary Care Initiatives, in particular, comprehensive medical assessment for permanent residents of residential aged care facilities (Medicare Benefits Schedule item 712), and Aged Care GP Panels, it is hoped that there will be much greater direct involvement of GPs in the care of their patients in aged care facilities. Overseas experience indicates that increased availability of primary care (both medical and nursing) in nursing homes results in fewer hospital admissions.6 The lack of communication between aged care facilities and the emergency department in 61% of presentations is also of concern. Use of a common aged care facility transfer sheet may improve this, and as the use of technology increases (eg, electronic care plans for residents), the use of electronic referrals may assist the process of information transfer. Inadequate communication or documentation between aged care facilities and emergency departments has been shown to increase the likelihood of admission to hospital.7 The preparation and use of advance care directives was also suggested by Finn et al to guide response to acute events occurring in residential care. Advance care directives (also known as “health care directives” or “living wills”) allow residents to document their preferences for treatment and care. The directives may indicate a desire for hospital admission and full treatment or a preference for limited treatment in certain situations. Many aged care facilities already encourage their use and help residents and their families formulate such directives in the weeks following their admission. Advice in preparing these directives is available from a number of sources, such as NSW Health.8 Finn and colleagues have given us an understanding of current presentations of patients from residential care facilities to emergency departments that can assist us in developing different and better quality services for these people. Adequate training and resourcing of staff in aged care facilities, increasing involvement of GPs, and consultation with residents and their families are the first steps in developing these services.

Susan E Kurrle MB BS, DipGerMed, PhD

Evidence “beyond reasonable doubt” may never be achievable for low-volume drugs The recent publication of a randomised controlled trial (RCT) of inhaled cyclosporin in the New England Journal of Medicine represents another milestone in the evolution of lung transplantation (LTx) as a standard therapy in the management of severe lung and pulmonary vascular diseases.1,2 RCTs have been few and far between in lung transplantation, and this is the first in such a high-profile general journal. However, the big question is: how will we integrate the study results into the clinical practice in Australia? Lung transplantation is a relatively recent and very demanding form of solid organ transplantation. The first long-term survivor received a lung transplant in 1981,3 and, compared with kidney and liver transplantation, there have been proportionally fewer lung transplantation procedures performed annually in Australia (100 lung, 400 kidney and 170 liver cadaveric transplants in 20044). Nonetheless, the four Australian lung transplant programs have performed about 6% of all lung transplants worldwide.5 At present, 100 Australians are awaiting suitable donor lungs. The efficacy of the various lung transplantation procedures themselves is determined primarily by comparison with historical control data, and the results of small cases series. The clinical practice of lung transplantation has generally developed by inference from other types of solid organ transplantation, as well as clinical anecdote and deduction. Indeed, we can identify only a handful of RCTs performed in lung transplant recipients that directly guide therapeutic decision making. Typically, the conduct of RCTs requires substantial resources and patient numbers. In lung transplantation, unless the effect size is huge, this typically mandates multicentre, multinational trials.6,7 Australian lung transplantation centres have recognised the need for good quality trials, and have consistently taken lead or major roles in virtually every significant RCT of an immunosuppressant published over the last decade.6-8 Five-year survival after lung transplantation (50%) lags well behind that of other forms of solid organ transplantation (kidney, 85%; liver, 80%4), and we continue to strive to increase our evidence base with the ultimate objective of improving clinical outcomes. Therefore, it seems somewhat ironic that, despite core Australian involvement in clinical trials generating evidence of the utility of newer immunosuppressive agents (tacrolimus, sirolimus, mycophenolate mofetil, everolimus), this evidence has not been readily integrated into Australian clinical practice. The reimbursed immunosuppressive protocols employed by lung transplantation programs in this country (cyclosporin, azathioprine and prednisolone) reflect decade-old practices. By contrast, in the United States, United Kingdom and Europe, newer agents have been rapidly integrated into practice. In Australia, there appears to be a progressively widening gap between the point at which there are sufficient data to support the use of a drug in a clinical situation (clinical risk versus benefit), and the point at which funding can be achieved that will allow the drug to actually be administered to patients. We submit that central to the problem in Australia is the extremely complex system of health care funding. Gaining Therapeutic Goods Administration (TGA) registration of a drug allowing it to be prescribed for a series of indications is only the first (relatively small) step. After that, there is extreme complexity as to who (if anyone) will pay. Previously, public hospitals have provided drugs that were indicated on clinical grounds but not subsidised by the (federal) Pharmaceutical Benefits Scheme (PBS). With a shift to predominantly casemix funding, hospitals with cutting-edge clinical programs have been forced to limit access to non-PBS items to prevent institutional “fiscal meltdown” from these largely unsupported costs. Generally, equitable access to an expensive drug in Australia requires listing on the PBS on the advice of the Pharmaceutical Benefits Advisory Committee (PBAC). The process is rigorous, evidence-based, and includes detailed pharmacoeconomic evaluation with a benchmark of cost-effectiveness. Our concerns are that the same level of evidence is required for frequently used medications (such as statins) compared with low volume drugs (such as anti-rejection drugs for lung transplant recipients) and the cost-effectiveness benchmark is not stated specifically. It is quite appropriate for regulatory authorities, hospitals and individual transplant physicians to appreciate the financial implications of novel agents, and not just focus on the evidence of efficacy. It is also important for 21st century physicians to recognise the commercial reality of drug patent laws, generic alternatives and pharmaceutical company marketing strategies. However, these issues create particular difficulties in small clinical fields like that of lung transplantation, where there may be sufficient evidence to support the use of a therapy, despite the absence of the multiple randomised trials specific to lung transplantation. It becomes apparent that it may not be commercially viable for a pharmaceutical company to perform the necessary trials and successfully negotiate registration and reimbursement for such a small patient group as lung transplant recipients. These issues are again brought to our attention by the recent RCT in the New England Journal of Medicine.2,8 This small single-centre RCT in lung transplantation is welcomed with great interest, as it shows efficacy for a novel inhaled cyclosporin formulation in enhancing key outcomes, including chronic rejection-free and overall survival (Box).2 The study had an accompanying editorial noting several methodological issues and, consistent with conservative evidence-based medicine, the editorial suggests the lung transplantation community undertake multicentre trials to avoid being “doomed to recreate a series of anecdotal experiences”.8 We are concerned, however, that repeating the RCT will take years to complete. Indeed, given the particular complexities of this agent, where multiple entities hold patents and licensing rights to different components of the therapy, no trial may ever be undertaken. There is a push to market the treatment on the existing evidence, and a case could be made that not to facilitate access to this novel therapy for Australian lung transplant recipients may cause greater harm by preventing the use of what appears to be a safe agent that strikingly reduces the risk of chronic rejection and death. We face a dilemma as lung transplant physicians (which we believe will resonate with many other clinicians) that on the “balance of probabilities” (to use a legal analogy), the benefits to our patient are likely to be greater than the risks, so it would be better to use the drug than not. However, to have the drug funded (and thus, available to our patients in a practical sense) realistically requires evidence “beyond reasonable doubt”. For the many reasons alluded to, this standard may never be achievable for low-volume drugs. Australia has been very well served by a centralised drug reimbursement system like the PBS, but we also believe it disadvantages patients with uncommon diseases who need high-cost drugs. If health economics are to be the principle determinant of funding, we need a transparent, consistent benchmark of cost-effectiveness across the entire health system. In the meantime, we ask that the thresholds of support for pharmaceutical funding be based on clinical appropriateness from the best available evidence, otherwise evidence-based medicine is in danger of becoming an economic weapon rather than a key clinical tool. Key findings of the inhaled cyclosporin lung transplant study2 Design and primary outcome 58 patients were randomly allocated, early after transplant, to receive 300 mg inhaled cyclosporin or placebo for 2 years, in addition to standard therapy. The primary outcome was rate of histological acute rejection. Results Acute rejection rates were the same for the two groups (0.44 v 0.46 episodes per patient; P = 0.87) Nephrotoxicity and opportunistic infection rates were similar. Survival was improved in the inhaled cyclosporin group (relative risk of death, 0.2; P = 0.01) Chronic rejection-free survival was improved in the inhaled cyclosporin group (relative risk of chronic rejection, 0.38; P = 0.01)

Greg Snell MB BS · Tom Kotsimbos MD, FRACP · Trevor J Williams MB BS, FRACP