Editorials

Crohn's disease is an important cause of morbidity in Australia, with a prevalence of about 50 per 100 000 population. The disease is most common in adolescents and young adults, but can occur at any age. The cause is still unknown, but research towards finding the cause is proceeding apace, along with improvements in diagnosis and advances in therapy. The development of Crohn's disease depends upon an ...

Warwick S Selby MB BS MD FRACP

In this issue of the Journal, Priest and colleagues report a further study showing the lack of effectiveness of "debriefing" after a traumatic event in preventing psychological disorders — in this case, in women after childbirth.1 Their use of debriefing for this purpose indicates how widely the enthusiasm for this intervention has spread in the past decade. On superficial examination, early interventions are an appealing ...

Alexander C McFarlane MD, DipPsychother, FRANZCP

This issue of the Journal (page 575) features the last article of the EBM in action series,1 conceived to show how clinicians can effectively look for the best available evidence to answer clinical questions. In the current medical climate, clinicians clearly need systems to obtain the best available evidence, and the responsibility for creating these systems falls on both individual clinicians and the organisations for ...

Christopher B Del Mar MD FRACGP · Jeremy N Anderson MD FRANZCP

Action plans are not a "quick fix", but only part of a care package requiring doctors' time and commitment Providing an individualised written asthma "action plan" is a particularly high-profile part of Step 6 of the Australian Asthma Management Plan: "Educate and review regularly". The idea of a written action plan is that the patient is given a set of rules by which to alter therapy, dependent on either peak expiratory flow monitoring or symptom levels. The implication is that an appropriate, early response to deterioration will prevent dangerous exacerbations and will generally improve health-related quality of life. Written action plans for asthma are perceived to be so important that they became one of the two Australian Council on Healthcare Standards Performance Indicators for quality assessment of acute respiratory medicine in Australian hospitals. However, the evidence — whether from research or from clinical practice — that written action plans, in themselves, are effective is equivocal. There are now a number of Cochrane Collaboration Airway Group systematic reviews that examine this area, but the outcomes are inconsistent. Gibson et al analysed up to 36 studies comparing self-management, education plus regular practitioner review against usual care.1,2 They found that active intervention significantly reduced hospitalisation, emergency room visits, unscheduled visits to the GP, days off work or school, nocturnal attacks of asthma, and quality of life, but that lung function was not altered. Self-management programs that involved a written action plan were more effective than those that did not, but regular doctor review seemed to be most important. Indeed, a review by Toelle et al failed to find consistent evidence that written plans, of themselves, have any effect on asthma control.3 Powell and Gibson found that optimising asthma control through adjustment of inhaled corticosteroid dose could be as well achieved by written guidelines for the patient as by seeing their doctor to adjust the dose.4 Somewhat paradoxically, there was evidence that removing regular doctor visits from a management plan was deleterious. Verbal and written instructions to patients seemed equally valuable: the intensity of education seemed to be more important than the format of the advice. But is the proof of the pudding in the eating? If so, ownership of written action plans seems to be falling in Australia although it was never particularly popular in the asthma community. A community sample in South Australia showed a fall from 42.3% in self-reported ownership of written plans in 1995 to 22.2% in 2001, as reported in this issue of the Journal (page 483).5 Furthermore, a large epidemiological study conducted recently in Melbourne also indicated a fall in written action plan use, albeit from an even lower base: in 1999 just 13.3% of Victorians with self-reported asthma had ever been given such a plan, compared with 19.9% in 1993.6 The current situation and available facts therefore raise more questions than they answer.7 Why is uptake of written action plans so disappointing? If written action plans work, why are they not more popular? What is their main purpose — is it to prevent exacerbations or to control day-to-day levels of disease activity? Studies have shown that written action plans are viewed positively by patients, but in practice, they modify their plans according to their own perceptions and experience of asthma.8 It is important that doctors realise this and give patients time to explore such issues and then incorporate them into an agreed plan. Indeed, the role of doctors is very important — their degree of empathy with patients and the amount of time they give to management issues have significant outcome effects in asthma.9 Presumably this "doctor effect" will extend to the uptake and usefulness of asthma action plans. What seems certain is that action plans cannot be used as a substitute for regular detailed review and comprehensive education of patients with asthma. Developing long-term relationships with their doctors, accompanied by being involved in discussion and decision making is important.9,10 Data suggest it is the "process" not the written action plan per se that is currently at fault. Complicating the delivery of asthma care is the poor training of doctors in creating or delivering care packages involving negotiated action plans. Indeed, the main reason for patients not having a written asthma action plan is that they are not given one by their doctor!8 Longitudinal studies are needed to evaluate the effects of enhancing physicians' "participatory decision making" style9 on outcomes of patients with asthma, especially in general practice, where most such patients are managed. This is particularly so in light of the year-old Commonwealth Government-funded national initiative for asthma management in the community, in which a 3+ visit plan in general practice11 provides a framework for optimising treatment and education. This plan includes a written action plan for patients with moderate-to-severe asthma. This needs to be rigorously assessed in routine clinical practice, as even the best ideas and most worthy initiatives from professional "enthusiasts" can be confounded through lack of sufficient time and commitment. Evidence shows that patients will not cooperate with any intervention that is less than fully backed by the time and authentic personal commitment of their doctors. Yet, in a pressurised fee-for-service system, it can be difficult to sustain interest and enthusiasm in the long term. In conclusion, the uptake of asthma action plans in Australia is disappointing, especially as we know they can be useful as part of the right package. Perhaps the management of chronic diseases like asthma needs different sorts of practitioners in a different professional and funding milieu. Yet another challenge for our beleaguered healthcare system?

E Haydn Walters MADM BCh FRACP · Julia AE Walters BM BCh · Richard Wood-Baker DM FRACP

Forewarned is forearmed Severe Acute Respiratory Syndrome (SARS) is now a global phenomenon, but it remains heavily clustered in mainland China, Hong Kong, Toronto, Singapore and Hanoi.1-5 The world is fearing a global pandemic, but it is not happening as initially predicted. Although there are some uncertainties regarding particular clusters of cases, such as the Amoy Garden Estate in Hong Kong (where about 300 people in one block of flats were affected), the primary mode of spread appears to be by infected droplets, and healthcare staff taking strict barrier precautions appear to be protected. There is some evidence that the virus is present in all body fluids, including faeces and urine, so taking precautions with waste disposal are also recommended. World Health Organization case definitions of severe acute respiratory syndrome (SARS) The WHO case definitions of SARS, revised as of 1 April 2003, for a suspected and a probable case of SARS: 6,7 A "suspected" case of SARS is a person presenting after 1 November 2002, who gives a history of high fever (> 38°C), and cough or breathing difficulty and one or more of the following exposures during the 10 days before the onset of symptoms — close contact with a person suspected of having SARS, or a history of travel to or residing in an affected area. A "probable" case of SARS pneumonia is a suspected case (as defined above), with radiographic evidence of infiltrates on chest x ray consistent with pneumonia or respiratory distress syndrome, or a suspect case with autopsy findings consistent with the pathology of respiratory distress syndrome, but without an identifiable cause. The World Health Organization case definitions of "suspected" and "probable" SARS are given in the Box. The clinical course of the disease follows a 2–16-day incubation period,4,5 with high fevers, chills, rigors and myalgia. In contrast to the WHO definition, respiratory symptoms are not prominent and many cases have presented with diarrhoea, abdominal pain and loss of appetite (unpublished observations). There are very few patients with abnormal findings on chest examination at presentation, but these changes develop in severe cases after admission to hospital.5 Laboratory tests typically show a reduced white cell and lymphocyte count, with a mild increase in the platelet count. Usually after 2–3 days of symptoms, x-ray changes become apparent. Typically, the changes are air-space consolidation, predominantly peripheral and often unifocal initially, but progressing over days to bilateral, multifocal changes. At around 7–10 days, about 20%–30% of cases deteriorate and require admission to an intensive care unit. Of these, about half require assisted ventilation. The overall mortality rate is 3%–5%, but may be higher in elderly people. Treatment has been largely empirical and usually has included an antiviral agent, such as ribavirin, and steroids.5 High-dose steroids have been effective in reducing fever and progression of x-ray changes, with the clinical response and radiological features suggesting bronchiolitis obliterans organising pneumonia as the possible underlying pathology.5,8 It is unclear whether any of these treatments alter the ultimate course of the disease. Intravenous administration of convalescent plasma has also been trialled, in the belief that antibodies may halt the progression of the disease,5 despite a theoretical risk of introducing another viral load. Currently, there are a number of possible aetiological candidates, with corona virus being the most likely;9-11 however, a metapneumovirus from the paramyxovirus group12 has also been suggested. Unfortunately, in our experience, field testing for the viruses has so far been unconvincing. It is unlikely that, in the short term, there will be a reliable diagnostic test or vaccine, although work is progressing at a rapid rate. In Australia, the response to SARS has been dichotomous — varying from panic that SARS will be another pandemic to complacency that this is another region's problem. It is likely that Australia will be less affected than countries with open land borders and crowded cities with poor hygiene control. However, the outbreak in Toronto shows that any Western city may have to manage such an outbreak.3 If this disease spreads in clusters rather than sweeps through communities, then the public-health response must be different. It is clear that hospitals and healthcare workers are particularly at risk. In Hong Kong, in the first weeks of the outbreak, 25% of patients with SARS were healthcare workers.5 The healthcare sector has to be particularly prepared, as this is most likely where a cluster will start. Revision of infection control, with meticulous attention to detail, is important. At the Prince of Wales Hospital, Hong Kong, it took three weeks to bring the secondary infections in staff down to near zero. Despite this experience, other hospitals in the region did not take heed, and many more staff in these hospitals became infected because of suboptimal infection control procedures. It is to be hoped that hospitals in Australia will learn from this experience. Screening potential cases of SARS is particularly difficult, as the signs and symptoms are vague and consistent with virtually any viral illness. Following up patients over a number of days is the only way of ascertaining whether they have SARS. The question of whether to admit all suspected cases to hospital is also an issue. If suspected cases are admitted, they may actually contract the disease in hospital. If they are discharged, they may infect their families and friends. In our recent experience of screening about 1000 people with suspected SARS, we uncovered over 100 confirmed SARS cases. We found that there was no secondary spread among the suspected cases followed at home with strict quarantine instructions. All people with confirmed SARS were admitted to hospital. Guidelines for screening high-risk contact and low-risk non-contact subjects have recently been published, although there are no good studies evaluating their utility or the quality of the supporting evidence.13 SARS will fundamentally change the interaction between primary healthcare workers and patients, in much the same way that AIDS changed the way we handle blood products, with universal precautions to protect ourselves from potential HIV infection. It is likely that, in the future, all healthcare providers in regions where SARS is endemic will use the standard droplet precautions of a mask, goggles, gown and gloves for all patient contact. SARS has the potential to totally disrupt the healthcare system of cities or states. Apart from the potential to use hundreds of general ward beds — a disaster in itself given the bed capacity of most Australian hospitals — the biggest threat is the need for intensive care unit (ICU) beds. If 20%–30% of cases required care in ICU, and a cluster of 200 cases occurred in Melbourne or Sydney, there would be little likelihood of finding 50 ICU beds at short notice. A further problem is that ICU staff are likely to contract the disease (unpublished data). If a number of staff contract the disease in an already overstretched ICU system, this may precipitate a fall in morale and staff departures. Furthermore, many nurses are of child-bearing age, and the antiviral agents and high-dose steroids used in the treatment of SARS are likely to be teratogenic. Health authorities need to think about their ability to provide "surge capacity" — not only in terms of ventilators, but also in terms of trained staff. This might include multiple-skills training for nurses and doctors working in non-intensive-care areas. Some healthcare epidemiologists have suggested that this disease is no more serious than the usual winter influenza outbreaks, and not nearly as serious as a new mutation of the influenza virus would be.14 The difference is that previously we have not seen a healthcare system paralysed for a period of months from the impact of one infectious agent. The annual reported death toll from influenza is mostly due to its impact on elderly people, who may die anyway. SARS puts young healthy people into ICU, and otherwise healthy people die. The death toll from SARS is undoubtedly higher in the elderly, and we have not yet seen what may eventuate if a SARS outbreak occurs in a retirement home. The sensible response of Australian health authorities is to remain on high alert, review infection control procedures within hospitals, develop contingency plans for a possible surge in demand for general and ICU beds, and develop an evidence-based approach to screening and quarantine procedures for potential cases.

Peter A Cameron MB BS, FACEM, MD · Timothy H Rainer MB BCh, FHKCEM, MD, FHKAM · Pieter De Villiers Smit MB ChB, FACEM

The findings of two major trials show that rhythm control is not necessarily superior to rate control There are two broad strategic options in managing recurrent or persistent atrial fibrillation (AF). They are: Rhythm control, in which treatment is directed toward restoring and maintaining sinus rhythm; and Rate control, in which AF is allowed to continue or recur unimpeded, and medications are given to control ventricular rate.1 It has been a widely held and natural assumption that rate control is inferior to rhythm control. Theoretically, the advantages of maintaining sinus rhythm should include fewer thromboembolic complications, reduced need for anticoagulation, and less cardiac failure. In short, fewer deaths and fewer symptoms. However, antiarrhythmic medications have only modest efficacy for preventing AF recurrences, both symptomatic and asymptomatic, so rate-controlling and anticoagulant drugs must also be used in many patients being treated primarily for rhythm control. Also, antiarrhythmic medications can have serious side effects, including life-threatening proarrhythmia and, in the case of the commonly used drug amiodarone, pulmonary fibrosis, thyroid dysfunction and hepatic toxicity. Until recently, few randomised trial data have been available to gauge the extent to which these practical deficiencies offset the potential benefits of rhythm control.2 Now, two major trials comparing the two treatment strategies have been published.3,4 The larger AFFIRM trial was conducted in North America, with all-cause mortality its primary endpoint.3 The smaller trial was conducted in the Netherlands, and had a composite primary endpoint which included heart failure, thromboembolism, bleeding, need for pacemaker implantation, death from cardiovascular causes, and other severe adverse effects of drugs.4 The primary finding in both trials was that rate control was not inferior to rhythm control, and that there were some trends towards superiority of rate control. In the AFFIRM trial, 5-year mortality was 21.3% for rate control versus 23.8% for rhythm control (P = 0.08). In the Dutch trial, the primary endpoint occurred in 17.2% (rate control) versus 22.6% (rhythm control), also narrowly failing to reach conventional significance. For the patient populations studied (minimally symptomatic; mean age, 69 ± 9 years; most with at least one prior episode of AF), these findings indicate that the benefits of the rhythm-control strategy do not, in general, outweigh the risks. What drugs were used? In AFFIRM, by physicians' choice, amiodarone was used in 38% of patients being treated for rhythm control initially, and in 63% at some time in the trial. Sotalol was used in 31% initially, and 41% at some time. Other drugs, including propafenone, procainamide, quinidine, flecainide, disopyramide, moricizine and dofetilide were each used in less than 10% of patients. In the Dutch trial, sotalol was used initially, but replaced (if AF recurred within six months) by propafenone or flecainide, and then, if necessary, by amiodarone. Warfarin treatment could be stopped at the physician's discretion when sinus rhythm had apparently been maintained for four weeks after cardioversion. The detailed outcomes quantify the impact of shortcomings of these antiarrhythmic agents. Sinus rhythm was present in 62.6% (AFFIRM) and 39% (Dutch), respectively, of patients being treated for rhythm control at the conclusion of the trials. The proportion of patients taking warfarin remained above 70% in the AFFIRM study, and above 86% in the Dutch trial. Most disappointingly, the strategy failed to reduce the rates of stroke, other thromboembolic complications, or haemorrhages compared with rate control (see Box). Of the 80 ischaemic strokes incurred in the AFFIRM trial's rhythm-control arm, 55% occurred after discontinuation of warfarin. A further 21% occurred during warfarin treatment, while patients' international normalised ratios (INR) were < 2.0. Only 31% had AF at the time of their stroke. These findings suggest that it may be unsafe to stop anticoagulation for AF patients treated with a rhythm-control strategy, unless there are no other risk factors for stroke (age > 60, previous stroke or transient ischaemic attack, hypertension, rheumatic valve disease, diabetes, cardiomyopathy, planned or recent cardioversion) and/or maintenance of sinus rhythm has been demonstrated not only by lack of symptoms, but also by appropriate ambulatory ("Holter") monitoring.1,5,6 The rate-control arms had significantly lower rates of severe adverse effects attributable to medications — effects such as torsade de pointes, resuscitated cardiac arrest due to bradycardia or pulseless electrical activity, and various non-cardiac adverse events (see Box). The incidence of congestive cardiac failure was non-significantly lower in the rate-control arms in both trials. In subgroup analyses of the AFFIRM trial, rate control had lower risk of death for patients older than 64 years, those without pre-existing congestive cardiac failure, and those with coronary artery disease. A trend in favour of rate control in patients with hypertension in the AFFIRM trial is supported by superiority (primary endpoint 17.3 % v 30.8% for rhythm control) in the corresponding subgroup analysis of the Dutch study. These two trials do not spell the end for electrical cardioversions and antiarrhythmic medications in the management of AF. They concentrated on older, high-risk patients, excluding or under-representing some subgroups of patients who experience AF, for example: patients considered unsuitable for one of the strategies (eg, those with hypertrophic cardiomyopathy, those too symptomatic in rate-controlled AF, or those at unacceptably high risk of bleeding with anticoagulation); and patients under 65 years of age and with no other risk factors for stroke or death. For many such patients, and for most patients' first episode of persistent AF, it remains appropriate to cardiovert once, with a level of anticoagulation appropriate to the patient's risk–benefit profile for some weeks or months, meanwhile treating any concomitant predisposing conditions (congestive heart failure, lung disease, etc), and then review. Many issues need to be considered when deciding and revising optimal treatment in an individual patient. In selected individuals, potentially curative non-pharmacological treatments (eg, pacing,7 catheter ablation,8,9 or maze operation10) may be appropriate. However, for patients represented in the AFFIRM and Dutch trials, a line in the sand has been redrawn. Rate control is safe and should not be considered inferior to rhythm control for minimally symptomatic patients in whom AF is considered likely to recur after cardioversion, particularly if they are older than 64, or have coronary artery disease or hypertension. Healthcare professionals should make assiduous efforts to help patients maintain their INR between 2.0 and 3.0 continuously, and to achieve adequate rate control (defined for the AFFIRM trial as resting rate ≤ 80 beats per minute, and either a 6-minute walk test with a rate ≤ 110, or a 24-hour Holter recording with average rate ≤ 100 and no individual rate more than 110% of the predicted maximum).11 Summary of the findings of two major studies examining rate control and rhythm control in atrial fibrillation AFFIRM3 Dutch study4 Number of participants 4060 522 Mean duration of follow-up 3.5 years 2.3 years Mean age at baseline 70 years 68 years Females 39% 36% Event Rate Rhythm Difference significant? (P ) Rate Rhythm Difference significant? Primary endpoint* 21.3% 23.8% No (0.08) 17.2% 22.6% No Congestive heart failure 2.1% 2.7% No (0.58) 3.5% 4.5% No Thromboembolism 5.5% 7.9% No Cerebral 5.5% 7.1% No (0.79) Other systemic 0.5% 0.4% No (0.62) Pulmonary 0.1% 0.5% No (0.16) Haemorrhage 4.7% 3.4% No Primary intracerebral 1.1% 1.3% No (0.73) Subdural or subarachnoid 0.8% 0.8% No (0.68) Non-central nervous system 7.7% 6.9% No (0.44) Severe adverse effects of drugs (other than anticoagulants) 0.8% 4.5% Yes Torsades des pointes 0.2% 0.8% Yes (0.007) Resuscitated cardiac arrest due to bradycardia or pulseless electrical activity < 0.1% 0.6% Yes (0.01) Pulmonary events† 1.7% 7.3% Yes (< 0.001) Gastrointestinal events† 2.1% 8.0% Yes (< 0.001) Bradycardia† 4.2% 6.0% Yes (0.001) Prolongation of corrected QT interval (> 520 ms)† 0.3% 1.9% Yes (< 0.001) Other adverse events† 14.0% 25.4% Yes (< 0.001) * All-cause mortality for the AFFIRM trial,3 and a composite primary endpoint which included heart failure, thromboembolism, bleeding, need for pacemaker implantation, death from cardiovascular causes, and other severe adverse effects of drugs for the Dutch trial.4 † Prompting discontinuation of a drug.

Michael J Kilborn FRACP, DPhil

Differences in kava extraction methods may affect hepatotoxicity In this issue of the Journal, Gow and colleagues (page 442) report the first Australian case of fulminant hepatic failure attributed to a herbal product containing kava,1 while Moulds and Malani (page 451) note the cultural and economic importance of kava for Pacific island nations, and provide a balanced overview on kava safety and availability.2 For centuries kava has been widely consumed in Pacific island countries as a ceremonial beverage and for its mood-altering and stress-relieving properties. It is prepared as an aqueous emulsion of the crushed fresh or dried roots or lower stems of the kava shrub Piper methysticum ("intoxicating pepper").3 Pharmacological properties, such as anxiolytic activity, are attributed to a poorly characterised group of compounds termed kavalactones.3,4 In 1982, kava was introduced to some Arnhem Land Aboriginal communities from Pacific island countries, in part to reduce the harmful effects of alcohol.5 Kava use continued to rise during the 1980s and 1990s, supplied by a lucrative black market. Concerns about adverse health, social and economic effects of widespread heavy consumption resulted in the Northern Territory Kava Management Act in May 1998, which made the possession of more than 2 kg of kava illegal unless in accordance with a licence. However, an illegal trade continued, with profiteering by those distributing kava imported from several Pacific island countries. In October 2000, the Kava Management Act was amended to incorporate harm reduction objectives and a system of licensed kava supply, controlled by local Aboriginal community organisations. Over the last decade, there has been an expanding global market for herbal preparations made in Western countries and containing kava extracts.4 These products have been marketed for the treatment of anxiety, insomnia, premenstrual syndrome and stress, and sold over the counter as complementary medicines or dietary supplements.6 Since 1999, cases of severe hepatic toxicity in people using kava-containing herbal products have been reported from Europe and the United States.6,7 Subsequently, kava-based herbal products have been banned in some European countries, including the United Kingdom. In Australia, a practitioner alert and consumer advice were issued in February 2002 by the Therapeutic Goods Administration (TGA) concerning hepatotoxicity possibly related to kava-containing products. By late 2002, eight cases of liver transplantation after hepatic failure associated with use of kava-containing products had been reported from Europe, and two from the United States.6 The patient reported by Gow et al died soon after liver transplantation.1 As a result of this case, the TGA initiated a voluntary recall of all complementary medicines containing kava extracts on 15 August 2002.8 The TGA has 87 products containing kava on its Australian Register of Therapeutic Goods.8 Although details are sketchy for many of the at least 68 cases of suspected kava hepatotoxicity,4 with the herbal products sometimes containing additional ingredients, the increasing number of well documented cases1,6,7 make it likely that kava extracts are responsible for occasional severe progressive hepatotoxicity. However, the mechanism of this toxicity remains to be determined. Histological examination has shown portal inflammation with lymphocytes and eosinophils,6,7,9 and an idiosyncratic immune response to a reactive metabolite has been suggested as a possible cause.9 In two patients, phenotyping of the activity of cytochrome P450 isoform CYP2D6 showed that they were "poor metabolisers", and it was postulated that genetic differences in liver metabolism of kavalactones may be important.9 Moulds and Malani discuss the paradox that fulminant hepatic failure has not been documented with traditional kava use in Pacific countries.2 Kavalactones in herbal products are usually extracted with ethanol or acetone,6 and may differ critically from the aqueously extracted kavalactones used in Pacific countries and Aboriginal communities. Of note is an early study of the health effects of kava use in Aboriginal communities, which documented consistent abnormalities in liver function tests in heavy kava drinkers.5 A recent study in Arnhem Land has confirmed these findings, with abnormal serum levels of γ-glutamyl transferase (GGT) and alkaline phosphatase (ALP) in 61% and 50% of kava users, respectively.10 However, serum levels of alanine aminotransferase (ALT) were not raised in any kava drinkers. Furthermore, the abnormalities in liver function usually return to normal within 1–2 months of stopping kava use.10 The raised GGT and ALP levels combined with normal ALT levels in Aboriginal kava users do not suggest acute inflammation and are not consistent with the changes documented in the cases of hepatotoxicity associated with herbal products, where aminotransferase levels are especially high.1,6,7 Clinical surveillance in the Northern Territory over 20 years has not documented any cases of fulminant hepatic failure attributable to kava use. This is despite Aboriginal kava drinkers consuming kavalactones in doses estimated to be 10–50 times the recommended therapeutic doses for herbal products.3 However, the recent study confirmed adverse effects of kava, such as kava dermopathy and lymphocytopenia,10 which were documented in the 1980s.5 Although a rigorous systematic review found kava to be an effective symptomatic treatment option for anxiety,4 herbal preparations should not be used until the mechanism for hepatic toxicity is clearly ascertained. The abnormal but reversible GGT and ALP levels seen in heavy kava drinkers does not reflect the same pathological process. Whether the apparently idiosyncratic fulminant hepatic failure documented with herbal kava preparations can also occur with traditional aqueous extracts requires further surveillance. Close monitoring for this and other potential adverse effects of kava use in Aboriginal communities and Pacific countries is recommended, in addition to initiatives encouraging moderation in consumption.

Bart J Currie FRACP, DTMTH · Alan R Clough MSc

The overarching cause is energy imbalance The health and wellbeing of Australia's children and adolescents, now and in the future, is under threat. In 2002–2003, the most prevalent child health issues affecting children are preventable: obesity, dental disease, emotional and behavioural problems, bullying and learning delays. These problems often present as comorbidities. Overweight and obesity affect about 23% of Australian children and adolescents, with 6% being obese.1 These are conservative estimates, as there has been no systematic monitoring of the prevalence of overweight and obesity in Australian children and adolescents since 1995. However, over the previous decade, the prevalence of overweight children almost doubled, and the prevalence of obese children more than tripled.1,2 There is no reason to believe that the rapid rise in prevalence rates has not continued. Studies of historical datasets have also revealed that the prevalence of overweight and obesity in children and adolescents doubled over the period 1985–1997, a far greater rate of increase than in the preceding 16 years.3 Health inequalities related to overweight and obesity are evident. There is a higher incidence of overweight and obesity in children of parents of particular backgrounds,3 and maternal education is the strongest social determinant of overweight and obesity in childhood.4 Although there are limited national data, and combined New South Wales, Victorian and National Nutrition datasets1 failed to find a rural/urban difference, Victorian epidemiological data show a statistically significant, higher proportion of overweight and obese boys in metropolitan areas, but this difference was not found for girls (Ms K Hesketh, NHMRC PhD Scholar, Centre for Community Child Health, Melbourne, VIC, personal communication). The health consequences of overweight and obesity are substantial, although Australian data remain unclear in certain areas.5 At least in the United States, obesity carries more stigma in children than any physical disability, and this is evident across all socioeconomic and ethnic groups.6 Issues of social acceptance, athletic competence and physical appearance are well known to obese children and affect their sense of social and psychological wellbeing. Obese children with decreasing self-esteem are more likely to smoke and drink alcohol compared with those whose self-esteem increases or remains the same.7 Obese children and adolescents may also have a range of medical conditions including hypertension, dyslipidaemia, and even type 2 diabetes. Other problems, such as musculoskeletal discomfort, obstructive sleep apnoea, heat intolerance, asthma and shortness of breath, greatly affect their lifestyle.8 Implications for the future can be gathered from longitudinal studies. Combined cohort studies indicate that relative body weight is sustained from childhood to adulthood, and, once children or adolescents are overweight or obese, their weight is unlikely to track backwards.5 If this is not sufficient reason for concern, reflect that these studies (of the long-term consequences of child and adolescent obesity) were all performed before the worldwide obesity epidemic developed. What, then, will be the outcome, in 10 or 20 years' time, of large numbers of children and adolescents entering adulthood, already with abdominal obesity and well established risk factors for cardiovascular disease and type 2 diabetes? Focusing on children highlights their contribution to contemporary society and future populations. Addressing the determinants of health and wellbeing for children and adolescents will improve population health and wellbeing overall. The overarching cause of the obesity epidemic is energy imbalance — a relative increase in energy intake (food intake) together with a decrease in energy expenditure (decreased physical activity and increased sedentary behaviour). Identifying the most important predictive determin-ants of each of these behaviours, as well as the most effective and sustainable remedial strategies, is complex and involves parental education and employment; housing environments; play, recreation and physical activity; food and nutrition; accessible active transport; and child-friendly physical and social environments.9 Some simple trends suggest relatively amenable remedies. Children's fruit and vegetable consumption has decreased over the past 20 years. Their physically active time has also decreased, while time spent in sedentary activities such as television watching and computer games has increased. Finally, consumption of energy-dense foods (including sweet soft-drinks and snack bars with a high sugar content) has increased. Possible remedies include: parental education strategies regarding healthy food choices, activity options, obesity trends, as well as supportive behavioural change strategies; supportive policies and environments in the places children and families spend their time (child care, school, workplaces, home, local neighbourhoods); and prioritisation of free time for physical activities. Evidence from controlled trials (although these trials are heterogeneous as regards the age groups and settings studied) highlights the potential for school-based programs that promote physical activity, modify dietary intake and reduce sedentary behaviours. However, recent qualitative research indicates that differences in outcomes will only be achieved if sustainable changes involve all generations, tackle the widely held beliefs regarding eating and activity,10 involve population-wide health promotion messages, and dispel myths such as children's overweight being just "puppy fat". Further, there are environmental aspects that are well beyond an individual family's ability to modify, including: regulation of marketing of unhealthy food choices for children; provision of safe, cheap and accessible public transport; and urban planning initiatives that give priority to child-friendly and pedestrian-friendly environments. The latter options are more controversial, and vested interests may seek to cloud the community's perceptions of factors driving the overweight epidemic. We need to actively involve industry in partnerships for environmental change. Health practitioners working in the community, child and family nurses and general practitioners are crucial in any comprehensive strategies, as they provide a widely available service to families and can tailor specific strategies for individual families.11,12

Elizabeth B Waters MPH, DPhil · Louise A Baur PhD, FRACP

The evidence for behavioural therapy Autism is a developmental disorder characterised by impairment of communication and social interaction, and stereotyped, restricted patterns of behaviour. The young child with autism fails to develop normal language and imaginative play. Autism (or autistic disorder) affects one in 1000 children and is the core disorder of a wider spectrum of pervasive developmental disorders. Australian paediatricians identify it as one of the more difficult areas of practice1 — there is still no cohesive explanation for the child's developmental arrest, and a plethora of therapies exist. Diagnosis needs to be made by a multidisciplinary team. Parents then face a long list of possible interventions, and will usually be directed first to speech pathologists. Sensorimotor integration therapy (which stimulates or desensitises visual, auditory and tactile senses), and dietary interventions (eg, casein and gluten exclusion) are widely practised in Australia, but data for their efficacy are inadequate.2,3 A controlled trial of auditory integration (where the patient listens to music that has been computer modified to remove frequencies to which he or she is hypersensitive) showed no effect, yet it continues to be offered as a therapy.2 While ineffective therapies may be harmless, they waste parents' money and the child's valuable therapy time. Furthermore, the delay in implementing effective treatment may compromise the child's outcome. Augmented communication, using visual modes such as pictures, symbols and signs, promotes communication and language in children with severe communication deficits and poor verbal imitation skills.4 However, the early intervention that has been subjected to the most rigorous assessment is behavioural intervention. There is now definite evidence that behavioural intervention improves cognitive, communication, adaptive and social skills in young children with autism. In 1987, Lovaas showed apparent recovery, persisting into adolescence, in nine of 19 young children who received an intensive home-based intervention based on applied behavioural analysis, a scientific method of reinforcing adaptive and reducing maladaptive behaviours.5,6 Subsequent studies also showed that behavioural intervention caused significant, albeit somewhat lesser, gains.7-11 This has modified the orthodox view that autism is always a severe, lifelong disability. Criticisms of the adequacy of the design and power of these studies are being addressed by the multisite Lovaas replication Early Autism Project. The first US site has released data (Wisconsin Early Autism Project).12 Again, after three to four years of intensive applied behavioural analysis intervention, about half the preschool children with autism acquired near-normal functioning in language, performance IQ and adaptability. Ninety-two per cent of intervention children acquired some language. Control children who received special education showed no gains in IQ or adaptability.12 Why is intensive applied behavioural analysis intervention more effective than special education for children with autism? This can not be simply explained by the intensity of these programs (30–40 hours per week). Children in a school-based Scandinavian study who received behavioural intervention gained an average of 25 language IQ points in the first year of the intervention, with improvements in performance IQ, communication and adaptability. On all scores, they surpassed control children who received special education according to best practice for autism, and the same intensity, duration and supervision of therapy.13 The superior outcome from behavioural intervention is thought to result from the targeting of specific deficits in autism that prevent learning: imitation, attention, motivation, compliance, and initiation of interaction. Skills are taught in small steps, mastered, and then generalised. Intensive, individualised one-to-one therapy is usually provided by students, behavioural therapists, or parents, under the supervision of behavioural experts. More natural settings of play and learning, augmented communication support, and other powerful visual learning tools, such as video modelling, may be used. Parents play a major coordinating role, and are trained to generalise the skills learnt by the child and to provide incidental teaching. Only positive reinforcement is used to teach the children. Several preschool programs in the United States and the United Kingdom report comparable success to home-based behavioural programs. These programs have low child-to-staff ratios, collect detailed behavioural data, generally integrate the children with typically developing peers, and train parents intensively in behavioural methods.14 However, most young children with autism in Australia do not receive intensive behavioural intervention programs — partly because such programs are not recommended by many health professionals and partly because of their prohibitive cost for families. Only Western Australia has achieved partial government funding for preschool behavioural programs, as justified by a review by the Disability Services Commission of Western Australia.15 This State is also the first to have a prospective autism register, placing it in a unique position to provide Australian outcome data. We are unaware of comprehensive Australian outcome data (from specialised preschools and schools for autism) with which to compare outcomes of applied behavioural analysis programs. For those of us who are parents of children with autism, this seems to be a pressing need. In the United States, parents have effectively advocated for evidence-based interventions using expert statements.2 If intensive behavioural programs in young children with autism allow about half of the children to no longer require special education and other costly interventions, government funding of such programs would provide economic returns in the long term. The returns to the children who respond and their families would, of course, be priceless.

Jennifer J Couper MD, FRACP · Amanda J Sampson FRACOG, DDU, COGUS

Reforms to the management of schizophrenia in Australia have stalled A decade ago, the management of schizophrenia languished in medicine's backwaters. Treatment still occurred in asylums, using drug therapies serendipitously discovered decades earlier. Even these had proved ultimately disappointing and were used in excessive doses, with inevitable serious adverse effects, a great deal of suffering and only modest benefit. Psychosocial treatments were similarly obsolete or simplistic, with a weak evidence base. Therapeutic nihilism was pervasive and stigma profound. The public knew little about schizophrenia and gave little thought to it unless they happened to be directly touched by the disorder in their own lives. The Burdekin Report graphically captured this bleak scenario.1 The situation 10 years on is much more promising. Spurred on by the reintroduction of clozapine, a new wave of drug discovery has produced a second generation of antipsychotic drugs. Because of their better tolerability, and boosted by potent marketing campaigns, these "atypical" drugs have now become the first-line treatment in Australia and have engendered greater optimism in managing schizophrenia. Psychosocial treatments have undergone a similar renaissance,2 with the advent of evidence-based family interventions, cognitive behaviour therapy for persistent psychotic symptoms, and vocational rehabilitation models. The first National Mental Health Strategy catalysed an overdue reform process and created a real sense of progress. Early intervention strategies, not seriously attempted previously in schizophrenia, were effectively developed in Australia, evaluated and exported.3 The prospects for people with schizophrenia never seemed better. However, the potential for greatly improved outcomes has not been realised in Australia. The daily reality for most people with schizophrenia is that quality of treatment and quality of life are relatively poor.4 Many live in poverty in substandard housing, having little to occupy their time and trying their best to cope, often with the aid of harmful amounts of legal and illegal substances. The plight of family members is also serious and all too often leads to frustration and despair. Despite the early intervention reform, which is being taken up enthusiastically overseas,3 long delays in obtaining treatment for first episodes of schizophrenia are still common. Treatment is typically withheld until it can no longer be denied.5 In 2002, the Mental Health Council of Australia was contracted by the Federal Government to conduct a comprehensive review of the mental health system. The review concluded that, despite a decade of reform, Australia still does not have effective or accessible mental healthcare. Serious under-resourcing was identified as the fundamental cause. By the end of the 1990s, the devolved and mainstreamed mental healthcare system had developed a raft of problems. The reform process had stalled behind the complacent facade of a "mission accomplished". A recent review of Victoria's mental health services by the State's Auditor General found evidence of unmet need, poor access to and continuity of care, and low levels of satisfaction with services — problems attributed primarily to under-resourcing.6 Similar problems are likely to exist in other States. Furthermore, a substantial proportion of people with schizophrenia, whose management requires a team approach with specialist review, are being managed in minimalistic fashion by general practitioners with insufficient support from a beleaguered and reactive specialist system. As a result, despite significant advances in treatment efficacy, there is a vast gap between efficacy and effectiveness, which could be bridged if it were possible to implement optimal evidence-based treatment. The Royal Australian and New Zealand College of Psychiatrists is poised to release new clinical practice guidelines for the treatment of schizophrenia.7 The guidelines emphasise the need for an optimistic therapeutic approach to treating schizophrenia, and stress that the social environment of people with schizophrenia needs to be improved (eg, through housing support, vocational rehabilitation and family support). The guidelines also endorse atypical antipsychotics as the first-line treatment for schizophrenia because they are better tolerated in the short term by the vast majority of patients.11 Some have claimed that these outcomes could be achieved if the "typical" (first-generation) agents were used in lower doses,12 but there is increasing evidence that this is not the case, and in practical terms such low-dose use of typicals is unlikely to be achievable. Used over longer periods, the atypical agents are showing a significant advantage in relapse prevention13 and lower rates of tardive dyskinesia than the typical agents. However, this has to be balanced against the increased risk of adverse effects, such as weight gain and impaired glucose tolerance. Clozapine is clearly superior to other drugs for managing "treatment resistant" patients and reducing suicide risk.14 Despite practical difficulties relating to its use (notably the need for routine blood monitoring), clozapine should be more widely used in Australia. Psychosocial treatments2 are now solidly evidence-based, but are still only sparsely available in Australia.15 This reflects a major failure of public policy and practice. The failure to continue the reform process means that what is currently on offer is little more than acute-phase containment of risk in a reactive and rationed manner, with, at best, rapid disposal to minimal outpatient care. It has been claimed that much current funding for mental health services is not put to good use and that replacing some existing practice with evidence-based interventions is all that is required.13 This is clearly desirable but a manifestly inadequate response, which also ignores the costs that would be involved in achieving such global change in clinical practice. Despite the much-emphasised high direct cost of treating schizophrenia,14 treating it adequately, let alone optimally, will cost substantially more, and will require a much more professional and proactive approach, with widespread community support. For disorders that are treatable but not yet curable, achieving better outcomes is quite feasible but comes at a threshold price (my estimate of that threshold would be at least $24 000, but further research is needed). Current direct costs are about $18 000 per patient per year,14 a figure that has been labelled high, yet which is clearly below this threshold. Indirect costs (eg, costs of social security, costs involved in reduced working capacity of family members and the patient, and prison costs) are very substantial and could ultimately be diverted to proactive direct treatment. In fact, treatment in psychiatry is not intrinsically expensive in contrast to other complex medical disorders, yet Australia provides less funding per patient with schizophrenia than many other developed countries. Sartorius claims that "there is enough money around to help those with mental illness, but it is not available because of the attitude of most decision makers and a large part of the general public towards mental illness and all that surrounds it".15 People with schizophrenia are most affected by the lack of funding. Members of the public do not discover this until a friend or relative develops the disorder, by which time it is too late. Australians need to consider the following question: "Are you willing to pay to make optimal treatment freely available? — you or your family may need it.".

Patrick D McGorry MD FRANZCP

Formal risk-based protocols and clinical audits of process indicators and outcomes are needed "Missed" myocardial infarction occurs when a patient with an unrecognised acute coronary syndrome is discharged from hospital prematurely. The correct diagnosis becomes apparent only when the patient has an infarct or cardiac arrest, or is later found to have biochemical evidence of myocardial injury. There has been a paradigm shift in management of patients with chest pain over the past decade, with the focus moving from establishing a diagnosis towards ensuring the safety of the management strategy. This change was heralded by the publication of Australian guidelines in 1996 that recommended: Initial risk stratification of patients using clinical variables; Admission of intermediate- and high-risk patients for 48 hours of clinical observation to identify those with recurrent ischaemia at rest or evidence of myocardial damage (raised levels of cardiac biomarkers or electrocardiogram [ECG] changes); and If these features are absent, stress testing to exclude exercise-induced ischaemia in all remaining patients before discharge.1 Studies in the United States showed that the period of observation can be shortened to eight hours without affecting patient outcomes.2,3 Management guidelines were updated accordingly.4 Missed myocardial infarction usually results from a breakdown in the system of care — the patient's risk has been underestimated or formal protocols have not been fully implemented. Two studies in this issue of the Journal provide excellent examples of hospital strategies to improve the safety of chest pain triage. Aroney and colleagues (page 370) demonstrate that implementation of a protocol adhering to current Australian guidelines4 minimises missed myocardial infarction.5 They provide a benchmark for other hospitals to compare their practice. Boufous and colleagues (page 375) show that local implementation strategies can reduce medical error which contributes to missed myocardial infarction.6 A new "gold standard" for care. Aroney et al describe an "accelerated chest pain assessment protocol" that minimised hospital stay without jeopardising patient safety.5 After identifying intermediate-risk patients, they implemented a rapid, two-step process to ultimately identify those who were low risk and suitable for early discharge. They shortened the period of observation to a minimum of six hours. The absence of a single infarct in the 409 patients classified as low risk is an excellent outcome, clearly confirming the safety of the protocol. Of interest, 11% of the study population had diabetes but were safely triaged by the protocol. Thus, the recent recommendation to classify all patients with diabetes as high risk may not be necessary. Validation of new markers of increased risk, such as C-reactive protein, may allow risk-stratification algorithms to be further refined.7,8 Aroney et al achieved their outcomes in a large teaching hospital where coronary care nurses and "on-call" cardiology registrars were used to implement weekend stress testing, the final step in risk stratification before discharge. As many Australian hospitals have fewer resources, it is worth identifying non-essential elements of the protocol. The study data allow limited assessment of the incremental value of each step in the protocol, excluding the 78 patients who were unable to perform an exercise test. Most of the remaining 142 at-risk patients were identified by clinical, ECG or cardiac biomarker findings. Continuous ST-segment monitoring detected less than 2% of at-risk patients. As this monitoring is expensive, its use is difficult to justify in smaller hospitals. On the other hand, 42 at-risk patients (30%) were identified by an exercise ECG. Thus, this test should not be omitted. Coronary angiography was recommended in high-risk patients, but was performed in only 41%, as many were frail or had significant comorbidities. It is interesting to speculate whether outcomes in this group could have been improved by attention to optimal medical therapy and routine stress imaging. Are patients selected appropriately? Aroney et al do not report the numbers and outcomes of patients who were classified as low risk at initial clinical assessment and who were therefore not included in the study. Some at-risk patients may have been misclassified and discharged prematurely, predisposing them to missed myocardial infarction. Boufous et al audited this phenomenon.6 Their method was imperfect, as the reviewing cardiologist had to rely on the original clinical records. Despite this reservation, it is reassuring that formal adoption and use of a risk-stratification algorithm by clinical staff halved the rate of inappropriate discharge from 20% to 10%. Nevertheless, some potentially at-risk patients were discharged against current guidelines. The study was too small to detect an impact on their outcomes, and, to my knowledge, there are no published data on outcome in this group. However, the value of such a study is illustrated by an eight-month audit of emergency chest pain triage performed at my institution five years ago. Using a risk-stratification algorithm, we identified 136 intermediate-risk patients who were discharged contrary to guidelines. In most cases, patients were observed for at least eight hours, and serial biomarkers were measured. The guideline violation was primarily a failure to perform exercise stress testing, either because it was not available or because there was no in-patient bed to hold the patient until the test could be performed. Outcome was determined in all patients at one month. One death (documented ventricular fibrillation after recurrent chest pain) and five myocardial infarctions occurred during this period: three of these events, including the death, occurred within 24 hours of discharge. While the outcome for this group of patients was not statistically different from the outcome in 116 patients managed appropriately and discharged within 24 hours (one missed myocardial infarction), the clinical significance of the data persuaded our hospital managers to fund exercise stress testing on weekends. Coupled with an education program and a protocol similar to that described by Aroney et al, we subsequently reduced our underadmission rate substantially. How can hospitals improve triage of chest pain? It is unlikely that there will ever be high-level evidence to guide chest pain triage. As outlined above, poor outcomes such as missed myocardial infarction arise through medical error or inadequate resources, and the changes required to conduct a randomised trial would reduce the likelihood of the former and, by ethical necessity, ensure the latter. In the absence of high level evidence, hospitals should adopt methods to improve clinical practice,9,10 such as strategies similar to those described by Aroney and Boufous. Risk stratification and standardised protocols can reduce medical error, as shown by Boufous et al.6 To optimise bed use, all hospitals should adopt accelerated chest pain assessment protocols similar to that described by Aroney et al.5 Lack of stress testing, particularly at weekends, is the major impediment to their widespread adoption. To inform local resource allocation, hospitals should audit indicators of process, such as appropriate risk stratification and underadmission of at-risk patients. They should also measure patient outcomes, and, if these outcomes do not match those of Aroney et al, then hospitals should revise their current management strategies.

M Andrew Fitzpatrick MD FRACP

Careful assessment of car accident risk in patients with sleep disorders should guide advice Alcohol and excessive speed, often combined with inexperience and youthfulness, are the most widely recognised causes of motor vehicle accidents (MVAs). There is, however, increasing recognition that fall-asleep MVAs contribute significantly to road accident statistics.1-5 The typical fall-asleep accident involves a sole driver driving at night or in the early afternoon "siesta" period at relatively high speed.1 As with other causes of MVAs, fall-asleep accidents are more common in men under 30 years.1,3,5 In this issue (page 396), Desai and colleagues6 describe seven cases of fall-asleep fatal MVAs, and highlight the inconsistent way in which the New South Wales legal system dealt with these cases. They also draw attention to the role of sleepiness and sleep disorders in these cases, five of which involved under-treated or unrecognised obstructive sleep apnoea. These case studies are, by any measure, tragic, involving as they do serious injury, loss of life and, in several instances, imprisonment of the driver. They raise the question as to what role the medical profession might have in the prevention of such accidents. Obstructive sleep apnoea is the most common clinical sleep disorder leading to daytime sleepiness. About 26% and 10% of the Australian adult male population have ≥ 5 and ≥ 10 sleep apnoeas or hypopnoeas per hour, respectively.7 However, it is important to maintain perspective when thinking about this issue. First, while obstructive sleep apnoea is very common, most people with sleep apnoea will never have an accident due to sleepiness or be at significant risk for an accident.8 The relative risk for MVAs among all people with obstructive sleep apnoea is about 2–7 compared with the general population. This seems high, but is similar to the increased risk associated with driving at night,1 or for young drivers compared with older drivers. Second, sleep restriction (lack of sleep) is at least as common and is possibly of greater concern with respect to fall-asleep MVAs.5 The drivers with sleep apnoea described by Desai and colleagues all had mild-to-moderate obstructive sleep apnoea, which normally would not be associated with a high risk of an MVA,9 but, as acknowledged by the authors, the commercial drivers in particular were probably also sleep-deprived. In one case, prior sleep deprivation appeared to be the sole cause of the fall-asleep MVA. Nevertheless, there are patients with obstructive sleep apnoea who constitute a real and immediate risk to other road users. How does a medical practitioner identify and advise these patients, to try to prevent the tragedies so graphically described by Desai et al? The approach I would advise is as follows. First, establish good rapport with your patient and his or her family. A confrontational approach or immediately raising the possibility of revoking the driver's licence will lose you the patient. The emphasis should be on maintaining doctor–patient confidentiality, appealing to the patient's social responsibility, and the fact that, with appropriate diagnosis and treatment, most patients with sleep disorders can drive unrestricted. Assessing the effect of a patient's sleepiness on their driving Ask about instances of falling asleep while driving (eg, wheels on the verge or hitting the "cats eyes", lane drifting, previous fall-asleep crash) Seek corroborative history from the spouse or partner Ask patient to fill out the Epworth Sleepiness Scale questionnaire,10 which takes about five minutes. It requires patients to rate their chance of dozing in eight specific situations. The normal value is < 10 out of a maximum possible score of 24. A score > 15 indicates severe sleepiness and has been associated with substantially increased risk of fall-asleep MVAs.3 Consider additional causes of daytime sleepiness. Sleep restriction is very common and sleeping for less than five or six hours for even one night significantly increases the risk of a fall-asleep MVA.3,5 Second, make an assessment about the level of sleepiness and its possible impact on driving risk in your patient (Box). It would be unreasonable and totally impractical to send all patients with obstructive sleep apnoea for daytime sleep latency tests to determine level of sleepiness. Third, consider your patient to be in a "high-risk" category if there is a history of (1) a recent fall-asleep accident, (2) repeated "near-miss" fall asleep episodes while driving, (3) repeatedly falling asleep in other active situations (eg, during conversation, at meal table), or if your patient has a very high score on the Epworth Sleepiness Scale.10 Current Australian guidelines for healthcare professionals11 indicate that such "high-risk" patients should be instructed to stop driving immediately while referral to a sleep specialist and further investigation and treatment is arranged. If you consider that your patient is sleepy but does not fit the above "high-risk" categories, it may nevertheless be wise to advise him or her to reduce the risk of an MVA by avoiding night or country driving and by abstaining from all alcohol before driving. Fourth, keep careful notes. Ideally, all patients with obstructive sleep apnoea should be informed verbally, and in writing (eg, a pamphlet) if possible, about the increased risk of fall-asleep MVAs and the need to exercise care while driving. Special provisions apply if your patient wishes to apply for or renew a commercial or heavy vehicle driver's licence. Current Australian guidelines for healthcare professionals12 recommend that the licence be withheld if obstructive sleep apnoea (of any severity) is diagnosed, unless and until it is successfully treated. A conditional licence should be recommended (ie, restrictions imposed) if the driver has sleep apnoea symptoms of any severity until these symptoms are investigated. Thus, the burden of proof of driver safety has been deliberately increased for commercial drivers who have or are suspected of having obstructive sleep apnoea. Current uniform national driver licensing laws in Australia place the legal responsibility on drivers to notify their State/Territory licensing authority that they have a medical condition likely to affect their driving. If effective treatment for obstructive sleep apnoea (or any other sleep disorder) cannot be instituted within a reasonable time frame, and if your patient refuses to restrict driving as advised, you should remind him or her of this obligation. Finally, what is your ethical and legal responsibility if you have reason to believe that, against your advice, your patient is continuing to drive while seriously impaired? I believe at this point public safety takes precedence over patient confidentiality. Also, you could be found liable in the case of serious injury or death in the event of a fall-asleep accident should you fail to take reasonable steps to prevent your patient driving in a dangerous manner. You should advise the patient that, in the interests of public safety, you must inform the licensing authority. This action can and will annoy some patients, but legislation in all Australian States and Territories (Western Australian legislation is under review) provides medical practitioners with legal indemnity under these circumstances. The National Road Transport Commission will soon release new medical standards for drivers of all vehicle types. These will provide specific advice for medical practitioners relevant to licensing and driver safety across a wide range of medical conditions, including obstructive sleep apnoea.

R Doug McEvoy MD, FRACP

Infarct angioplasty has the potential to increase the disparity in outcomes between rural and urban patients with myocardial infarction The need for rapid treatment of coronary syndromes has been recognised for many years. Despite recent emphasis on the benefits of rapid thrombolysis, the main advantage of early presentation remains resuscitation from ventricular fibrillation. Defibrillation has been estimated to save about six times as many lives as thrombolytic treatment,1 but patients must reach medical assistance in time for it to be effective. On average, patients delay more than an hour before seeking help for symptoms of acute myocardial infarction, and about another hour elapses before they arrive at hospital.2-4 Attempts to shorten patient delay by education campaigns have been generally ineffective5 and, in recent years, efforts have been mainly directed towards expediting transport and hospital treatment of patients with myocardial infarction.2,3,6 In Australia, these efforts include fast-track pathways and delivering thrombolysis in emergency departments, before cardiological review.2,7 Significant improvements in call-to-needle times have been achieved,6 but, as Kelly and colleagues document in this issue of the Journal (page 381),2 not all patients are treated as rapidly as is desirable. The study by Kelly et al is particularly useful because it includes many of the patients treated with thrombolysis in Victoria over their study period of 30 months, and includes patients from rural and urban regions. Their data show that patients from rural areas delay longer before seeking attention and are slower to receive treatment than patients from large urban areas. While the association between delay in treatment and increased mortality in this study is likely to be partly confounded by unmeasured variables, few would dispute that these delays increase infarct size and the likelihood of dying during and after hospitalisation. Delayed treatment of myocardial infarction is one more manifestation of the geographic gradient in healthcare and outcomes in Australia.8 Controlled trials have shown that prehospital thrombo-lysis reduces mortality by about 20%.9 Prehospital thrombolysis is particularly suitable for remote regions with long ambulance transport times, and has been successfully implemented overseas without the use of mobile intensive care units.10 Even in urban areas, significant reductions in treatment delay have been achieved (between 30 and 60 minutes9), perhaps partly because a diagnosis is established before patients arrive at hospital and the hospital assessment process is circumvented. Yet, in Australia, prehospital thrombolysis has not been implemented in a systematic way. Kelly et al identify many of the barriers to the use of prehospital thrombolysis, including lack of appropriate ambulance equipment and failure to train and empower paramedics and nurses to give thrombolysis.2 They argue for a "bottom up" approach where individual healthcare ser-vices develop and own their strategies. Unfortunately, by itself, this is unlikely to effect change because of the complex funding mix of healthcare services in Australia and the parlous financial state of many rural health services. While rural and regional centres struggle to treat patients expeditiously with limited resources, metropolitan hospitals with cardiac catheterisation laboratories are moving steadily towards infarct angioplasty instead of thrombolysis.11 Whether this proceeds on a 24-hour basis depends mainly on the ability of individual cardiology departments to corral the necessary resources from their hospitals and the willingness of their staff to work nights and weekends. There is a strong body of evidence showing that infarct angioplasty is a better treatment than thrombolysis,12 but it is certainly more expensive to institute upfront. Proponents argue that it is cost effective compared with thrombolysis as it reduces hospital stay, but experience has taught hospital administrators to be wary of these claims as they rarely result in real cost savings. However, there is little doubt that infarct angioplasty is here to stay and that it will improve outcomes from myocardial infarction in patients fortunate enough to have access to it. If current trends continue, it has the potential to further increase the disparity in outcomes between rural and urban patients with myocardial infarction. How then should we respond to the data provided by Kelly and colleagues? Time delays in administering thrombolysis need to be seen in the context of the emergence of widespread use of infarct angioplasty and the particular geographic difficulties imposed by the Australian setting. In areas with transport times of more than 20 minutes, systematic use of prehospital thrombolysis could substantially improve outcomes at a modest cost. In urban areas, rapid transit to a facility with the ability to perform percutaneous transluminal coronary angioplasty (PTCA) is likely to become the standard. A combination of the two strategies could also be trialed in patients from areas without rapid access to PTCA (so called facilitated infarct angioplasty). Finally, in the debate about how best to achieve early revascularisation, it should not be forgotten that most of the delay occurs before the patient contacts the ambulance service and that, in this period, death is usually the result of ventricular fibrillation. As no strategy has been identified that encourages patients to present earlier, research should be directed towards improving the treatment of cardiac arrest with interventions such as prehospital thrombolysis13 and public access defibrillators.14

James W Leitch MB BS, FRACP

Building a patient's trust is just as important as following the letter of the law The cases and discussion in the article by Braunack-Mayer and Mulligan in this issue of the Journal (page 277)1 provide informative examples of legal and ethical dimensions of confidentiality and privacy in doctor–patient relationships. It is important to clarify the foundations and scope of both legal and ethical duties. In law, information provided to a medical practitioner by a patient becomes subject to a statutory duty to protect the patient's privacy and a common-law duty of confidence owed by the medical practitioner to the patient. *A failure to fulfil this duty is not an offence, although it can be the foundation of a complaint to the Office of the Privacy Commissioner. Privacy Act 1988 (Cwlth), section 36. †There is specific legislation in the Australian Capital Territory (Health Records [Privacy and Access] Act 1997), New South Wales (Privacy and Personal Information Protection Act 1998) and Victoria (Health Records Act 2001), and other States are actively considering such legislation, including New South Wales in relation to health information. Statutory duty. The statutory duty* varies according to whether federal or state legislation applies.† The federal Privacy Act 1988 applies to health information used by a private organisation and permits use or disclosure of such information without the patient's consent in a specified list of circumstances.2 Those that relate to the examples given by Braunack-Mayer and Mulligan are (a) disclosure for purposes directly related to the purpose of collection in ways that the patient would reasonably expect;3 and (b) disclosure that is reasonably believed to be necessary to prevent or lessen a serious and imminent threat to a person's life, health or safety.4 The scope of the statutory duty is not yet clear, as guidelines5 and public interest determinations6 issued by the Federal Privacy Commissioner indicate. Common-law duty. The common-law duty arises from a contract between patient and doctor or the presumption that the relationship is one of a class to which the law attaches that obligation. The duty is said to encourage patients to disclose full information so that medical practitioners can provide effective healthcare, a basis for a public interest in such duties of confidence.7 Correctly understood, it is not a duty to keep all information secret, but a duty to use the information only for the purposes for which it was provided and not for any other purpose.8 Medical ethics. In ethics, the duty of confidence in medical practice has strong historical origins in formal statements of medical ethics. Different translations of the Hippocratic oath recognise that the duty applies only to some and not to all information. These statements include "what should not be published abroad",9 "things shameful to be spoken about",10 and "things that should never be blurted out".11 Thus, its scope can be described by reference to the purpose of the disclosure.12 The justifications for this duty include a respect for patient autonomy and an expression of the professional virtue of fidelity.13 In Cases 1 and 2 presented by Braunack-Mayer and Mulligan, Ms X's and Mr Y's information was clearly provided for the purpose of providing diagnosis, advice and/or treatment to them. Their doctors' uses of that information to clarify a diagnosis, confirm decisions about treatment or seek additional advice could fairly be described as uses for that same purpose. As such, those uses would not be breaches of the common-law duty of confidentiality. However, the particular use described in Cases 1 and 2 may not conform to the Privacy Act, as it seems clear that neither Ms X nor Mr Y reasonably expected that use of their information. (There is no suggestion that the disclosure was reasonably necessary to prevent or lessen a serious and imminent threat to their life, health or safety.) The legal and ethical implications of access to Ms Z's test results in Case 3 are less clear, because of the involvement of two medical practitioners and the lack of explanation as to how the second doctor had access to the test results. Clarification of these details is important. However, if there was an explanation of access, it is clear that the information was used for the purpose of diagnosis and treatment, the purpose for which it was provided. Ms Z's being unaware of that use remains relevant for the Privacy Act. Thus, the common-law duty of confidence may not have been breached by any of the doctors in the three cases. The statutory duty to protect privacy may have been breached, depending on clarification of some uncertainties of interpretation. However, what remains important is that the patients all plainly felt that their information had been used in ways that surprised or troubled them. It could be said that the patients thought that an ethical duty had been breached. It seems there were two main causes for their concern, both of which have ethical importance. First, they did not know about (and did not feel that they had consented to) the way their information was used, and, second, that use diminished their trust in their doctors. Consent that is based upon an adequate and clear disclosure of how information will be used is the best response to the first cause of concern. Being given that information and, in turn, giving consent also respects a patient's autonomy. Routine advice as to whom a patient's information will be disclosed in the course of using it for diagnosis and treatment will probably also meet the requirements of the Privacy Act.3 Further, patients can, by their consent, agree to wider uses or disclosures of their information. As to the second cause of concern, acting in order to generate and maintain a patient's trust is the best response. In doing so, a doctor expresses the virtue of fidelity. This lies at the foundation of the doctor–patient relationship: it extends beyond merely keeping promises (eg, to maintain confidentiality) and speaks to character and the establishment, and not the assumption, of a relationship of trust.14 The authors are correct to identify the ethical importance of attending carefully to patients' awareness of and understanding about how their information is used. Exceeding minimal legal duties by doing more than merely making patients aware of how their information will be used is important to building trust and to providing effective healthcare.

Colin JH Thomson BA LLB LLM

The IF is a poor measure of the worth of journals, journal articles and authors Tell me the number; what is the ranking? All of us seem to love ratings. Whether it is the standings in the Rugby World Cup, the box office success of Harry Potter or the melting rate of Arctic ice, we all want numbers. So, why would it be any different for medical journal articles or even medical journals themselves? Who attaches importance to medical journal ratings? The owners/publishers of the journals, readers, advertisers, librarians and journalists may all be interested in journal ratings to varying degrees. Likewise, authors have a need to discern just how a publication is valued before deciding where to send the products of their labours. How can we evaluate the quality of an article or a journal? Properties of a medical journal that can be assessed include total circulation; readership numbers and surveys; quality of the editorial board, staff and peer reviewers; number of manuscripts received, percentage accepted, and turnaround; Science Citation Index (SCI) raw numbers, Immediacy Factor and Impact Factor (IF); number of paid subscribers; advertising revenue; listing on Medline; international distribution; cost to the reader; and page or peer-review charges to the author.1 But what do authors most value? Frank and colleagues have surveyed the Stanford University School of Medicine faculty regarding the factors that influenced their decisions about where to send manuscripts. The top attribute selected was "prestige".2 Impact factors are also used to adjudicate on academic performance. Some universities, especially in certain European countries, have decided that the IF of journals in which a faculty member publishes will enter into personnel decisions such as appointment, promotion and rate of pay.3 One would like to think that intelligent deans, chairs of departments and administrators, who work daily with faculty members, would have a better way to ascertain quality of performance than an arbitrary number. Seglen, of Norway, was an early critic of the IF, drawing attention to its narrow worth, and calling for its application to be reined in3 — but apparently to no avail. My belief is that the IF has one specific meaning: it is a clear measure of the extent to which a given journal functions as a connector of researchers in a specific field. This is one (but only one) critical function of medical journals. When I began as the editor of JAMA in 1982, JAMA's IF was in the range 3–4. Some considered this an embarrassment, so we set out to raise the IF as part of our efforts to improve the quality of the journal. We succeeded, to the extent that by the time I left the journal in 1999 its IF was in the range 10–11. Strange as it may seem, during the mid-1990s I deliberately tried to slow the growth of JAMA's IF. I was afraid that we were changing the character of the journal away from its fundamental purpose — to be useful to all doctors in their practices — and too far towards a research journal, used by researchers to communicate with each other. In this issue of the Journal, Walter and colleagues4 (page 280) criticise the IF, clarifying what it is and what it isn't. They describe an alternative way they have devised to judge the quality of articles (and presumably journals, if article scores are aggregated and averaged), using a five-person voting method guided by six criteria. It would have been interesting to see a side-by-side comparison between the article rankings of the selection panel and the SCI IF scores for each article. Walter and colleagues' form of post-publication peer review is now into its second year. The authors invite others to try it, and I hope there will be some who take up the challenge. In 1982, when I and my colleagues were developing plans to celebrate the JAMA Centennial, we tried an approach to evaluating medical articles somewhat like that of Walter et al. We wished to identify and republish the best 50 articles from the first 100 years of JAMA as "landmark articles". A list of prospective articles for inclusion was compiled from three sources: nominations by JAMA editorial board members and staff, entries in the 1976 edition of A medical bibliography (Garrison and Morton), and the most-cited JAMA articles from the Institute for Scientific Information. A total of 150 articles were nominated. The editorial board and staff then ranked the articles by a Delphi process and the top 50 were named "landmark articles".5 The article publication dates ranged from 1884 to 1968, with representatives from each decade. A subsequent analysis of the landmark articles by Eugene Garfield, founder of the Institute for Scientific Information (and father of the noted [or notorious] IF), demonstrated that of the 100 JAMA articles most cited by SCI up to 1983 only 13 were among the top 50 landmark articles, garnering from 174 to 506 citations by 1987.6 Thus, 37 landmark articles were not included in the top 100 JAMA articles ranked by total citations alone. Notably, such hugely important articles as those of Salk7 and Sabin et al8 had only received 39 and 90 citations, respectively, by 1987. So, number of citations and the derived IF are connected, but only to a limited degree. I would hesitate to suggest that the post-publication peer review process described by Walter et al could supplant the IF as the way that academic institutions, or even governments, decide on the merit of a publication or an author. But I can say with conviction that man (and academia) should not live by numbers alone.

George D Lundberg MD

Previous recommendations for preventing allergic disease need to be critically re-examined A marked increase in allergic disease has occurred over the past century. For example, between 1992 and 1997, the prevalence of asthma increased by 26% and skin-prick sensitivity to house dust mite (HDM) increased by 63% in Australian children.1 In determining the causes of this increase it is important to distinguish between primary and secondary causes of allergic disease. Primary causes are those considered to induce allergic disease in a non-sensitised person, while secondary causes are those that trigger symptoms in people who are already sensitised. Primary prevention strategies are aimed at reducing sensitisation. In the early 1980s it was considered that a clean environment, avoidance of pets, the provision of synthetic "allergy free" bedding (rather than feather bedding) and prolonged breastfeeding were all important in primary prevention. But recent epidemiological studies have challenged these beliefs. There is evidence that a clean environment in early life may actually promote rather than inhibit the development of allergy. The "hygiene hypothesis" is based on epidemiological studies comparing the prevalence of allergic disease in "clean" and "dirty" environments. For example, children growing up in East Germany before the fall of the Berlin Wall had a lower prevalence of allergic disease than children in West Germany, despite having more exposure to pollution and infection.1 These results have been confirmed in similar comparative studies. Other relevant studies supporting the "hygiene hypothesis" have demonstrated fewer allergies in children from large families, in younger siblings, in children exposed earlier to day-care centres, and in children growing up on farms in Europe. Prevention programs for allergic disease have recommended avoidance of pets, particularly cats. However, recent studies showing either less asthma or less sensitisation among children exposed to cats in infancy have challenged this view.2,3 Exposure to cats in infancy does not appear to increase the risk of developing asthma. With regard to sensitisation, the evidence is conflicting, with some studies suggesting decreased sensitisation following cat exposure in infancy and others indicating the reverse. Cat exposure is associated with increased environmental levels of bacterial endotoxin. There is a hypothesis that endotoxin derived from pets may play a role in the prevention of allergy, as endotoxin can induce immune deviation away from "allergic" TH2 responses. The common belief that feather bedding promotes and synthetic bedding prevents allergic disease is now in doubt. This belief arose because of purported allergy to feathers or accumulation of HDM allergen in feather products. In fact, feather pillows contain up to eightfold lower levels of HDM allergen and accumulate this allergen more slowly than synthetic pillows. Children using a feather quilt are less likely to be sensitised to HDM.4 Prospective studies show that use of feather bedding in early childhood is associated with reduced asthma5 and use of synthetic bedding with increased asthma6 in later childhood. Studies of bedding are potentially complicated by selection bias: children with asthma may preferentially use synthetic rather than feather bedding, because of the widely held belief that synthetic bedding is less harmful. It is widely believed that breastfeeding should be recommended for primary prevention of allergic disease. Exclusive breastfeeding beyond four months of age reduces the development of atopic disease in early life,7 but the long-term benefits are now in question. One study has suggested that breastfeeding increases both asthma and allergen sensitisation in adult life;8 however, the fact that the breastfeeding was not necessarily exclusive may be a possible confounder. Another study demonstrated a protective effect of breastfeeding in early life but increased asthma in older children.10 A parental history of allergy is the most important risk factor for childhood allergy. What, then, are we to recommend to parents? Firstly, it is not possible to guarantee that any steps taken will prevent allergic disease. It seems reasonable to recommend exclusive breastfeeding for at least four months to increase the chance of reducing allergic disease in early childhood. It is not clear that the benefits extend to later life. Currently, it is not possible to provide firm recommendations on allergen reduction measures. Local environmental factors are important for HDM replication, and the benefits or otherwise of measures to reduce HDM exposure in infancy need to be demonstrated in the local environment. An Australian study of the effect of HDM reduction measures in infancy is in progress and the results are awaited with interest. Feather pillows or Doonas do not need to be avoided and may in fact be more beneficial than synthetic bedding. Once a child is sensitised, there may be a role for effective HDM encasing on any type of bedding, although again not all studies agree on this issue. Avoidance of household pets is not likely to prevent the development of allergic disease and cannot be recommended as a prophylactic measure. Nevertheless, it is advisable for clinically sensitive patients. It is clear that we need to critically re-examine the previous recommendations given to parents.

Andrew S Kemp FRACP PhD

We have the tools to improve prescribing — the challenge is to use them Australia's place among the world leaders in the quality use of medicines is exemplified by its National Medicines Policy, the framework of which was put in place over 10 years ago.1 At the centre of the policy is the goal that medicines are used wisely — the Quality Use of Medicines (QUM) acronym has since become somewhat hackneyed and maybe the time is ripe to replace it by a less pretentious label. This issue of the Journal contains three reports that address issues related to QUM. Liaw and colleagues (page 203) examined doctors' perceptions of the Authority Prescribing system of the Pharmaceutical Benefits Scheme (PBS) and found (among other things) that doctors generally do not perceive the system as promoting QUM.2 South et al (page 207) describe how the use of laminated cards, which list guidelines for prescribing antibiotics for infections commonly seen in a paediatric hospital, significantly improved prescribing.3 Newby et al (page 210) found that computer-generated prescriptions for antibiotics in general practice are more likely than handwritten prescriptions to contain repeats, many of which are probably unnecessary.4 Each of these reports shows that, even a decade after the introduction of the National Medicines Policy, aspects of prescribing in Australia can be improved. Thus, it is timely to reflect on what we have been doing right, what we have not been doing right, and where there is still room for improvement. We have developed robust structures to promote QUM in Australia. For instance, Australian Prescriber commenced publication in 1975, and, despite a rather stormy career, continues to provide independent information on issues related to drug therapy. The first edition of Antibiotic Guidelines was published in 1978, and the Therapeutic Guidelines series now covers all the major therapeutic areas. The Australian medicines handbook was first published in 1998. An important initiative was the establishment in 1991 of the Pharmaceutical Health and Rational Use of Medicines (PHARM) Working Party (later Committee),5 which used its modest budget largely to fund projects studying QUM. This committee has been an important stimulus for QUM projects, rather like an "NHMRC" of drug prescribing. However, the committee did not have a mandate to fund ongoing programs. More recently, the National Prescribing Service (NPS) has been established. One of its major mandates is to put in place ongoing programs to improve prescribing, particularly of drugs listed on the PBS. Its continued funding depends on the demonstration of savings to the PBS. To date, the NPS appears to have largely managed to combine quality use with cheaper use, although it is the latter on which its survival depends. It has also managed its recent assimilation of Australian Prescriber in a mature manner. However, the NPS might have increasing difficulty in the future combining its cost-saving mandate with QUM, as this is not necessarily synonymous with cheaper use of medicines. There is also still an element of being "the new (rich) kid on the block", and the NPS has yet to define fully its relationship with established organisations involved with QUM in Australia, such as Therapeutic Guidelines (centred in Victoria), the Australian medicines handbook and the Drug and Therapeutic Information Service (DATIS) group (centred in South Australia), and State groups such as the NSW Therapeutic Assessment Group and the Victorian Drug Usage Advisory Committee. These have been some of the QUM successes, but what are the failures? Undoubtedly one has been the concentration of the Authority system of the PBS on cost saving rather than QUM. This was probably inevitable given that the accelerating expenditure on the PBS cannot be offset by savings elsewhere in healthcare. However, it is a failed opportunity as far as QUM is concerned. Another failure has been the continuing secrecy of the data submitted by pharmaceutical companies to the relevant advisory committees (such as the Pharmaceutical Benefits Advisory Committee [PBAC]) and on which the decisions on registration of drugs, their scheduling, and subsidisation by the PBS are based. Most of this information is not in the public domain, yet would greatly assist doctors and organisations in making good decisions about whether or when a drug should be used. In short, there is no good justification for this bureaucratic secrecy, and it undoubtedly hinders QUM in Australia. The recent putative moves to open PBAC deliberations to public scrutiny are to be welcomed. Another failure is the dependence of our drug evaluation system on fees paid by the pharmaceutical company applicants. It is a tribute to the professionalism of the evaluators that they appear to have largely retained their independence (but the secrecy surrounding the system does not allow for a definitive judgement). However, no regulatory system dependent on fees can ignore the interests of its payers, which are not necessarily the same as those of the Australian public, whom the regulatory system is supposed to serve. A further failure has been our inability to grasp the opportunities presented for QUM by the introduction of computerised prescribing. Unfortunately, this strategy seems to be following the same path as the introduction of computing into hospitals, where it was introduced very much as a management tool and not as a means of improving the quality of clinical care. So, where do we go next? First, the process to make bureaucracy more transparent should be vigorously pursued. Second, we should develop a national forum, for QUM issues. The NPS cannot provide that forum, as it has an overt cost-saving agenda, and its survival depends on it "blowing its own trumpet", sometimes at the expense of other bodies. Perhaps all the different organisations involved with QUM should form a QUM Society, and have national meetings to share results and experiences. Not only would that encourage cooperation rather than competition, it would also promote better recognition of the work of individuals involved in QUM. Most are in academic institutions, and QUM tends not to attract the research grants and publications that academia use to judge success. Third, we must quickly grasp the opportunities presented by computerised prescribing. Advertising must not be allowed to intrude into the prescribing process, automatic repeats for antibiotic prescriptions should not be allowed, and suitable incentives should be provided to ensure that decision support systems are embedded into prescribing software. Last, and most important, we should not rest on our laurels. Australia has done well, but QUM is a fragile flower, easily crushed by other forces, such as the economic imperative to support the pharmaceutical industry. My recent new experience in a country with far fewer resources than Australia has already taught me that much can be achieved with the wise use of resources (such as an essential drug list) I would previously have considered totally inadequate. We should not be in the thrall of the new — we already have the tools, and the challenge is to use them to maximum effect.

Robert F W Moulds PhD, FRACP

Needle/syringe programs have resulted in enormous savings in both lives and dollars Sixteen years after needle/syringe programs (NSPs) were first introduced in Australia, after a period of civil disobedience and amid intense controversy, the recent report Return on investment in needle and syringe programs in Australia1 has convincingly confirmed the effectiveness of NSPs in reducing HIV and hepatitis C virus (HCV) infection among injecting drug users. The report also draws attention to the program's low cost and high cost-effectiveness. Commissioned by the Commonwealth Department of Health and Ageing, the report summarises 778 years of data from 103 cities around the world. In cities that had ever had NSPs, there had been an average annual decrease in HIV prevalence of 18.6%, compared with an average annual increase of 8.1% in cities without such programs. Australia's NSPs were estimated to have cost Commonwealth and State governments $122 million by 2000, but the return on this investment was the prevention of an estimated 25 000 HIV and 21 000 HCV infections. By 2010, our NSPs will have prevented an estimated 4500 deaths from AIDS and 90 deaths from HCV. The savings to governments for HIV and HCV were estimated to be at least $2.4 billion (allowing for conventional government 5% annual discounting of future costs) or as much as $7.7 billion (without discounting). By any reckoning, this represents an enormous saving in both lives and dollars. In light of these outcomes, opposition to NSPs amounts to public health vandalism and financial recklessness with taxpayers' dollars. However, in spite of these gratifying health outcomes for investments in NSPs, the annual incidence of HCV in Australia continues to rise. Hepatitis C is a very common chronic infection in Australia. At least 80% of infected people have acquired HCV through injecting drug use. A recent report2 estimated that in Australia in 2001 there were about 210 000 people with HCV antibodies, of whom 53 000 had cleared their HCV infection, 151 000 were living with chronic HCV infection and 6500 were living with HCV cirrhosis. Furthermore, according to the report, despite the effectiveness of NSPs in reducing HCV incidence among injecting drug users (IDUs), there were 16 000 people exposed to HCV during 2001, representing a 45% increase on the estimated 11 000 incident HCV infections in 1997.3 The report also projected that the long-term sequelae of HCV infection, such as cirrhosis, liver failure and hepatocellular carcinoma, would all treble by 2020. These two reports1,2 raise several important questions. First, why have NSPs been so successful at limiting HIV infection among IDUs, but less effective in reducing HCV infection? One important reason for the apparent discrepancy is the greater infectiousness of HCV by blood–blood spread compared with HIV, and consequently its heightened transmission among IDUs. Another factor is the higher baseline HCV levels (of the order of 50%–70%) prevalent among IDUs when NSPs were introduced in Australia in the late 1980s.4 At that time, only one in 200 IDUs undergoing treatment in Sydney were infected with HIV.5 HIV appears to have entered IDU populations in Australia in the early 1980s, about 20 years after HCV.6 Second, why has HCV incidence continued to increase so rapidly in Australia throughout the 1980s and 1990s, despite early and vigorous implementation of NSPs? The answer appears to be a combination of the increase in the number of young people who inject drugs7 and the continued high incidence of HCV infection among IDUs, and in particular among young people who have recently started injecting drugs (around 20% of IDUs are infected with HCV within three years of commencing injecting).8 The heroin shortage in Australia beginning in 2000 may have interrupted the increase in the number of IDUs, but whether a shortage will persist is uncertain. It is too early to estimate the net costs and benefits of the heroin shortage, but one benefit has been the 25% drop in deaths from drug overdose between 1999 and 2000.9 Finally, what should be done? Alternative strategies that need to be considered (in combination with NSPs) include medically supervised injecting centres, drug law reform, a trial of medically supervised prescription of illicit drugs for treating refractory drug users, introduction of harm-minimisation strategies into prisons, and education programs to encourage people who do or might inject drugs to consider non-injecting routes of administration. Such strategies must be debated in the community and properly evaluated. As each new HCV infection is estimated to cost healthcare systems more than $10 000,10 such strategies make sound health and financial sense. Many IDUs ultimately abandon injecting illicit drugs — it is in everyone's interests that they are still healthy when they do so, to maximise the likelihood that they will lead normal and useful lives. With the recent confirmation of the effectiveness of NSPs in preventing HIV transmission, it is important that society continues to support these programs. This may appear self-evident, but closing down NSP centres is often politically popular, especially in marginal electorates in tight elections. We must not become complacent just because a feared epidemic of HIV among IDUs has not eventuated. There is no guarantee that it will not happen in the future, as has been seen in some other countries.11 Any loss of resolve in the commitment to NSPs increases the likelihood of an HIV epidemic among IDUs, with potentially disastrous consequences for other at-risk populations (such as female sex workers or Indigenous Australians) and thence for the wider community.

Matthew G Law PhD · Robert G Batey MD FRACP FRCP

Academic pathology needs to be reinvigorated For well over a century, pathology has played a pivotal role in our understanding of disease. Its principles underpin many of our teachings in medicine and surgery, for, as Rudolf Virchow — the eminent 19th century pathologist and founder of modern pathology — so aptly observed, "Through the application of its doctrines ... it helps to deepen biological knowledge, and to light up still further that region of the unknown which still envelops the intimate structure of living matter".1 In short, an understanding of pathology is an essential prerequisite to an understanding of medicine. Against this background, it is of serious concern to the Royal College of Pathologists of Australasia that the role of pathology has been downgraded and marginalised with the ascendancy of problem-based learning in Australian medical schools.2,3 It is true that medical curricula over the previous half century placed too much emphasis on the basic sciences at the expense of the social and communicative aspects of medicine. However, as so often happens when changes are made, the pendulum has now swung too far the other way, to the detriment of pathology and anatomy. As Sir John Lilleyman, past President of the Royal College of Pathologists (UK), recently observed, "Current students are taught everything about grieving, but little about the causes of death".4 By its very nature, problem-based learning involves a multidisciplinary approach to clinical problems.2 Sometimes the facilitator for problem-based learning sessions is not a medical graduate. Furthermore, pathologists in academia are now in such short supply that those remaining have limited time to participate in these sessions. (In one Australian university with a faculty of medicine, there is only one half-time academic in pathology, and another university no longer has an independent department of pathology.) The end result is reduced exposure of medical students to pathologists and loss of invaluable mentoring. Consequently, more and more teaching is falling on already overburdened hospital pathologists and registrars-in-training. Furthermore, pathologists in private practice are reducing their teaching commitments because of heavy workloads. Anecdotal evidence suggests that the recruitment of medical graduates into a specialist discipline depends on a number of factors. These include the exposure to that discipline in the medical course and in postgraduate years 1 and 2, and the presence of role models in particular fields. Over the past half century, Australian pathology has been fortunate in having people of stature in academic positions. A recent Australian Medical Association study5 showed that lifestyle issues are becoming an increasingly important subject in career selection. With the currently decreasing staffing levels in academic departments of pathology and lack of formal rotations into pathology in the immediate postgraduate years, there is every likelihood that future recruitment of Australian graduates into pathology will be difficult. We are currently awaiting the report into the pathology workforce of the Australian Medical Workforce Advisory Committee. It will provide recommendations on the number of training positions needed in each State to satisfy future workforce requirements. What can be done to reverse the decline in pathology, particularly in academia? Firstly, the profile of pathology needs to be raised in the pre-university, medical, and general communities. To this end, the College introduced "Pathology Week" in 2002. It involved laboratory tours for secondary-school students, meetings with medical students in some universities, and a dinner bringing together pathologists and leaders in the business community. This year, "Pathology Week" will be held on 10–16 March. Part of the purpose of the Week is to raise the profile of pathology in the wider community: very few Australians know what a pathologist does, despite millions of pathology tests being performed each year. The College has also produced educational material for members of the public and for students contemplating a career in pathology. The Federal Government, through its Quality Use of Pathology Committee, is seriously considering providing financial support to create teaching modules for use in problem-based learning courses. The aim is to ensure that medical graduates of the future have some knowledge of the proper ordering of pathology tests in clinical practice. The Federal Government has also supported the production of a new edition of the Manual of use and interpretation of pathology tests6 for use by students and the profession. Both these initiatives, while most welcome, are unlikely to have medical graduates clamouring to choose a career in pathology. The Academic Advisory Committee of the College has prepared a core curriculum for use in medical schools, although advice from various Deans suggests that a surplus of curriculum content already exists. At the end of the day, the "committee sitters" usually win out in such exercises. Until such time as academic salaries in all branches of medicine become more realistic and aligned with other sectors in medicine, the future of academic pathology looks bleak. As New Zealand and the United Kingdom are experiencing similar shortages,4 there is little likelihood that academics can be recruited from those countries. In exchanges of correspondence with various Deans of medical schools, one has suggested that the College should do more to assist in the recruitment of pathologists to our universities. Perhaps it is time for governments and the private sector to put their support behind academic pathology to help resurrect the field of pathology and ensure it receives due recognition in the curricula of our medical schools.

David Weedon AO, MD FRCPA

As medical curricula and the competencies required of new graduates evolve, evidence-based evaluation of these curricula should become routine Over the last two to three decades, many universities and medical schools have initiated curriculum reforms. The factors cited as drivers of this worldwide reform include the ever-increasing knowledge base, shift in the burden of disease, advances in technology, changing expectations of patients and societies, easy access to healthcare information via the Internet, need for cost-effectiveness, the quality movement and awareness of medical errors, and changes in the learning environment. As desired competencies of physicians have gone beyond factual knowledge and clinical skills, training programs need evaluation methods that measure these competencies As societies struggle with their healthcare systems and re-examine the question "What is a good doctor and how do we measure it?", medical schools, teaching hospitals, professional societies and regulatory bodies try to provide guidelines, answers and leadership. As a consequence, there has been a proliferation of competency lists, and the movement towards "outcome-based education".1 One of the more meaningful lists of competencies was developed as part of the Education of Future Physicians of Ontario (EFPO) project2 (Box) — the first six of the eight competencies in this list resulted from patient input. Competencies required of medical graduates*2 Medical expert–clinical decision maker Communicator–educator–humanist–healer Collaborator Gatekeeper–resource manager Learner Health advocate Scientist–scholar The physician as a person * Developed for the Education of Future Physicians of Ontario project. Medical educators have therefore been asked to redefine the required knowledge base, set of skills, attitudes and experiences of physicians at all levels of training, while devising outcome metrics (assessments) that would allow meaningful feedback to individuals, schools, training programs and the system as a whole.3,4 The design and identification of these outcome metrics continue to be a challenge and reflect to a certain extent the diverse missions of medical schools: As university students, medical students receive an advanced scientific degree, implying a depth of knowledge and mastery of scientific skills. Assessments and outcome metrics have traditionally concentrated on the scientific aspects of medicine, which appear narrow in light of the above-listed competencies. Medical schools prepare their students to function as doctors for the rest of their lives. In most parts of the world, the government or a professional body certifies and licenses doctors, endorsing them as competent practitioners of medicine. Reliable metrics of the quality of medical practice remain a major challenge. Non-adherence to accepted medical guidelines has many reasons.5,6 However, awareness of and use of guidelines has been a measurable effect of one recent curricular change, involving problem-based and self-directed learning along with regular assessments of skills and attitudes.7 Medical schools also prepare their students to function as interns and junior medical officers after graduation. In essence, the directors of house-officer training programs and their colleagues are some of the earliest sentinels of medical student performance. In this issue of the Journal (page 163), Dean and colleagues use the last aspect to collect performance data about recent graduates of the University of Sydney graduate-entry medical program.8 Using a self-assessment tool and collecting data from supervisors, they found that graduates of the new curriculum had better communication and teamwork skills, and that they approached patient care in a more holistic manner, while being more confident and willing to continue to learn. The graduates of the new program assessed their knowledge base as weaker than that of their traditionally trained colleagues, a fact that was supported by some, but not all, of their supervisors. Despite the weaknesses of the study design acknowledged by the authors, these results reaffirm the value of follow-up studies as outcome metrics of medical education.9 As the "officially" desired competencies of physicians have gone beyond factual knowledge and clinical skills, training programs need to institute evaluation methods that measure these competencies.10 While more quantitative measures are developed, and increasing numbers of new curricula are introduced, better communication and feedback is needed between the various levels of medical education to guide this process. Medical education is a continuum and a lifelong endeavour, and all its components — secondary schools, colleges, medical schools, training programs, practices, hospitals and professional societies — need to work together.5 As in any complex, interdependent system, frequent feedback is absolutely necessary; we need intermediate and surrogate markers to assess progress and allow us to take corrective steps. The present study provides one such marker, albeit limited.8 Similar data collection should be encouraged as a matter of routine to inform the system and improve the training of physicians.

H Thomas Aretz MD

First, let's decide what we really mean by phimosis Circumcision remains a topic of significant debate in Australia, even though there has been a marked reduction in the rate of circumcision in this country, which has reflected that of England, where 95% of boys were circumcised in the 1930s, declining to 6.5% in the early 1980s.1 In this issue of the Journal (page 155), Spilsbury and colleagues report that many boys are circumcised for phimosis before the age of five years, despite phimosis being rare in boys of this age.2 They reviewed all circumcisions in Western Australian hospitals between 1981 and 1999, recording that the rate of medically indicated circumcisions increased during that period, and that, if the 1999 rate remains stable, it would be seven times the expected incidence of phimosis in the group of boys aged less than 15 years. These findings imply a high rate of unnecessary surgery, similar to the findings from studies conducted in England.1,3 Spilsbury and colleagues define phimosis as "narrowing of the preputial orifice leading to non-retractability of the prepuce". Such a definition would result in many boys under the age of five years being diagnosed with a condition for which surgery is considered to be justified. Their use of the term phimosis seems to mean pathological phimosis. To clarify, the prepuce is regarded as normal in boys if non-retractable because of preputial adhesions, or if the skin is physiologically non-retractable because of narrowing (ie, physiological phimosis). Figure 1 shows a normal foreskin that is non-retractable. The terms phimosis and non-retractable are not sufficiently clear in isolation, and need to be qualified. Rickwood and colleagues have recently given a succinct definition, stating that the ". . . normality, with an unscarred and pliant preputial orifice, is clearly distinguishable from pathological phimosis [shown in Figure 2], a condition unambiguously characterised by secondary cicatrisation of the orifice . . .".1 The addition of the word "pathological" or "physiological" is necessary to differentiate the different prognoses for phimosis, and, if the foreskin is not retractable because of adhesions to the glans, that information needs to have been included in the definition and documentation. Thus, rewriting the extract from the article by Spilsbury and colleagues, "many boys are circumcised for (pathological or physiological) phimosis before the age of five years, despite (pathological) phimosis being rare in this group". Why does the rate of circumcision for phimosis exceed the expected rate of phimosis?Clearly, the word "phimosis" in isolation does not have sufficient power to separate disease from a normal condition. Further, if parents feel there will not be support from the general practitioner, they may complain of symptoms in their child for the purpose of avoiding the debate about the appropriateness of circumcision for cosmetic reasons. Alternatively, the GP may support the parents' desire to have their boy circumcised, but expect resistance from the surgeon, and thus tend to present the child as having a pathological diagnosis. Such manipulation is not surprising when dealing with such an emotive topic. Nor is it necessarily improper given the differing cultural and medical views on the value of circumcision. A further explanation for the high circumcision rate for (pathological) phimosis might be a reluctance to record non-medical circumcision as such, using the appropriate International classification of diseases codes.4,5 What is the optimal treatment for phimosis?A wide body of evidence shows that most boys can be treated successfully with steroid cream, and that circumcision is required only infrequently.6-9 Unfortunately, almost all of these studies lack the distinction between pathological phimosis, as defined by Rickwood et al,1 and other foreskins that are non-retractable either as a result of preputial adhesions or because they are physiologically non-retractable. However, clinical experience suggests that most cases of pathological phimosis can be successfully treated with steroid cream, provided the steroid cream is applied to the partly retracted prepuce three times daily. After 4–6 weeks the prepuce should be retracted at the time of bathing and after voiding.10 It also appears that even balanitis xerotica obliterans can be successfully treated without circumcision,11 particularly if steroid treatment is supplemented with the minor operation of preputioplasty, in which the distal end of the prepuce is widened.12 Unfortunately, because the use of the term phimosis does not recognise the variations of the normal foreskin, the roles of observation, steroid cream and circumcision have not yet been compared in a study that has used a rigorous definition of pathological phimosis. There remains debate about the care of the normal prepuce in infant males. Parents are usually advised not to touch it, whereas the normal hygiene approach to body parts is one of not hurting, but keeping clean. The latter policy may help prevent skin irritation at the end of the prepuce, which may be part of the cause of pathological phimosis and balanitis (although this needs to be supported by appropriate studies). Evidence-based discussion about circumcision with parents will only be able to occur once we have undertaken prospective studies of the care of the prepuce and the use of steroids for treating phimosis. Parents will then be confident that their uncircumcised boy will not develop disease attributable to the nature of the foreskin. However, we should first focus on integrating a standard definition of phimosis into the study protocols. In the meantime, we should respect the view of parents who regard circumcision as good treatment for their child, given certain provisos. One is that they have been made aware of other options. The other is that they are making an appropriately informed decision about the management of their boy's prepuce because they are aware that "phimosis" does not equate to "pathology", and "pathology" does not always need surgery. Finally, Van Howe et al warn that physicians who perform "involuntary" circumcision are required to provide full disclosure. However, they also warn that, "with current legal precedent, this may not be enough" to protect the doctor from legal action,13 further emphasising the need to develop sound definitions on which to base our treatment of the prepuce. 1: A normal foreskin that is non-retractable, with pouting of the most distal portion when gentle retraction is attempted. 2: This foreskin shows the dome configuration of a boy with "true" phimosis. The fibrosis and pinhole meatus are also seen.

Paddy A Dewan PhD, MD, FRACS

Despite the risks to unvaccinated children, compulsory vaccination is not the answer In a pluralistic society, there are many views on what constitutes acceptable child-rearing. In Australia and other Western societies, parental discretion is limited primarily by legislation against abuse or neglect. In treatment decisions, the legal starting point is that the united view of both parents is correct in identifying the child's welfare. A court will usually only override the parents' decision if the judge is convinced the child's life is endangered, such as when a child needs transfusion.2 Administration of a vaccine is never immediately life-saving in this sense, except in the case of post-exposure rabies vaccine,3 but vaccination satisfies ethical criteria for preventive interventions in children: it is effective, minimally invasive, and associated with significant societal benefits.3 Indeed, the highly favourable benefit-to-risk ratio of childhood vaccination is so well documented that healthcare professionals are understandably frustrated when faced with what seems to be an irrational decision by parents to refuse vaccination. This is especially so when this decision has resulted in failure to prevent a life-threatening illness, as in the tetanus case presented by Goldwater et al (page 175).4 This case raises issues for both the clinician and society. How do healthcare professionals understand and best respond to a conscious decision not to vaccinate? In a highly immunised population, what is the balance of risks and benefits to individual children and their contacts from refusal to vaccinate? Should a case such as this propel us towards compulsory vaccination? In Australia, vaccination is not compulsory, but various incentives and reminders aim to promote it. First, payment of the maternity allowance at 18 months and the childcare benefit requires up-to-date vaccination according to the Australian Childhood Immunisation Register (ACIR),5 unless a medical practitioner has notified the ACIR of a contraindication or serologically confirmed immunity, or has discussed conscientious objection with a parent. Second, at school entry, documentation of full vaccination is required in most Australian jurisdictions, with children who do not have such documentation or serological proof of immunity to specific diseases, such as measles, able to be excluded from school attendance if suspected cases occur. Although the United States is often quoted as having laws for mandatory vaccination, the practical effect of these laws is also limited to exclusion of unvaccinated children from school during outbreaks, although preschool attendance for such children can be barred altogether.6 Italy is one of a few countries where there is compulsory vaccination, but only for diphtheria, tetanus, polio and hepatitis B. However, this has not been enforced for many years.7 To find examples of truly compulsory vaccination, it is necessary to go back to the 19th century. In England, the Vaccination Act of 1853 made smallpox vaccination compulsory for all infants in the first three months of life, on pain of fine or imprisonment. Its enactment spawned riots in several towns and an active anti-vaccination movement. In 1898, a new Vaccination Act removed these penalties and introduced the concept of "conscientious objector" into English law.8 In present-day Australia, most parents whose children are not fully vaccinated are not conscientious objectors, but rather face practical barriers such as recurrent minor illness, work commitments, large family size or social disadvantage.9,10 Parents who are strongly opposed to vaccination comprise a much smaller group. Of a large sample of 1779 Melbourne children in childcare in 1997, only 13 (0.7%) had not received any vaccines.10 This is similar to the proportion of all children Australia-wide registered with Medicare for whom there is a registered conscientious objection.5 In general, such parents tend to be well educated, older, female and of Anglo-Saxon background.11,12 Qualitative data suggest that conscientious objectors fear possible but unknown, especially long term, adverse effects of vaccines, believe that lifestyle measures to improve general immunity are viable alternatives to protection from vaccines, and often mistrust the motives of healthcare providers.9,12 This limits the ability of healthcare professionals to present pertinent counterarguments. Indeed, there is some evidence that parents philosophically opposed to vaccination may have their objections reinforced by factual information about risks and benefits, because these facts do not accord with their beliefs about health and illness.13 In contrast, parents who are merely doubtful about vaccination are much more likely to be amenable to presentation of relevant factual information.9 Healthcare professionals communicating with such doubtful parents need to have their facts well prepared and be sure that they have ascertained the parents' specific concerns, particularly whether these arise from personal or family experience. This is all potentially achievable within a realistic timeframe for a standard consultation, using readily available material specific to Australia.14 In the current Australian environment of high immunisation rates, does refusal of vaccination pose risks to either the individual or the community? In the case of tetanus, the risk is limited to the individual, as the disease is not transmissible. The risk to the individual is highlighted by the US experience, where, with very high immunisation rates, 15 reported cases of childhood tetanus occurred between 1992 and 2000.15 Children unvaccinated because of their parents' beliefs accounted for 9/11 cases in school-aged children,15 although objecting families represent only 0.6% of families with children attending school in the US.16 For other transmissible vaccine-preventable diseases, such as measles, pertussis and poliomyelitis, the risk goes beyond the individual. In Colorado, schools with a higher percentage of objectors were more likely to have a pertussis outbreak, and at least 11% of vaccinated children in measles outbreaks acquired measles from contact with an unvaccinated child of objecting parents. In addition, there was a 22-fold (measles) and sixfold (pertussis) increased risk for the individual unvaccinated child.16 Similarly, in Germany, almost all cases of Hib meningitis occur in unvaccinated children of objecting parents.17 In closed communities of vaccination objectors, such as certain religious groups, very high levels of morbidity from diseases not present in the general community can occur, such as in polio outbreaks in the Netherlands.18 Although there are few such communities in Australia, there is a tendency for conscientious objectors to cluster in certain geographic areas, so the risk of transmission is amplified. Measles cases in Australia now arise exclusively from imported strains and the unvaccinated children of conscientious objectors have recently been highlighted as at risk.19 Parents should be made aware that a decision not to vaccinate, made on their children's behalf, exposes their child to significant risks, even in 2003. Persuasion, at both the clinical level14 and the societal level,5 is appropriate, but truly compulsory vaccination is not an option, either in Australia or in other comparable countries.6,7

Peter B McIntyre FRACP, FAFPHM · Alison H Williams MB BS, FRACGP · Julie E Leask RM, MPH

We need a coordinated approach to address the underlying problems in the health system The effects of access block on acute hospital services are most disturbingly reflected by patients on trolleys queued in emergency department (ED) corridors and ambulances circling hospitals, waiting to deliver acutely ill patients. The Australasian College for Emergency Medicine and the Australian Council on Healthcare Standards (ACHS) have defined access block for emergency patients as the percentage of all patients admitted, transferred or dying in the ED where their total ED time exceeds eight hours.1 For elective patients, access block is reflected in ballooning elective waiting list numbers and length of time spent waiting. Access block has been with us since the 1980s, but in recent years, in Australia, it appears to have become both endemic and critical across all our major cities.2,3 There is now evidence that access block causes poor patient outcomes and interferes with efficient hospital functioning.4,5 In this issue of the Journal (page 103) the impact of access block across Australia and potential solutions are outlined. Causes of access blockThe causes for this untoward development are not straightforward, but appear to correlate with major decreases in hospital bed numbers, community residential care facilities, and with changes in workforce and community attitudes. Bed numbers: In Australia, the total number of acute hospital beds has decreased over the past two decades, with a 15% decrease in public hospital beds occurring from 1995 to 2000.6 There have been concomitant decreases in inpatient length of stay, but the number of hospital admissions have also increased.7 There are now more day procedures and day admissions. Although some of these replace multiday stays, others represent new work or multiple admissions replacing a multiday, single admission.8 Concurrent with decreasing acute hospital bed numbers, access to residential care beds in the community has decreased, especially beds designated for high-dependency patients.9 This has increased demand on acute hospital services as elderly inpatients wait for long term placement or are inappropriately sent back to the community to avoid pressure on an already congested residential care system. Community-based treatments: Many patients with complex and chronic illnesses are now treated as hospital outpatients or in the community. However, when serious complications occur, patients frequently present to EDs, particularly if access to community healthcare services is not available. This lack of community support increases patient load on the acute care system. Workforce: No single person can master the high-technology solutions and complicated treatment regimens prevalent in acute care hospitals. At the same time, many elderly or infirm patients need basic nursing care, which at times is considered too mundane for highly trained hospital staff. Increasingly, the workforce model required in healthcare is team-based, with multidisciplinary input and multiple levels of expertise, even within disciplines.10,11 Training programs for doctors, nurses and allied health workers do not yet reflect this need. This imbalance between career aspirations, systemic needs and actual working environments results in dissatisfied workers or insufficient staff with necessary skills. These factors contribute to low morale, which further reduces workforce flexibility. Social changes: The demise of the extended family and changes in the demographics of marriage and childbearing have led to more elderly people living alone, and with greater feminisation of the workforce fewer people can be carers.7,12 Population projections indicate that the number of informal carers in the community (largely middle-aged women) will decline sharply as the baby boomers age and require care themselves. The default solution for many partially dependent people is referral to an acute hospital. Funding models: Payments to hospitals and healthcare providers are rigid and reward rapid treatment of uncomplicated conditions. In the community setting, payment is for episodes of care rather than continuity of care. Complicated emergencies, time-consuming conditions involving multiple medical specialties, and social issues stretch the time and financial resources required, and are dealt with piecemeal. Patients with complex or multiple problems frequently have no alternative but to attend a public hospital ED.11 Casemix payments in the acute care setting and fee-for-service models of payment in the community setting usually disadvantage patients who require longer stays and supported post-hospital care. Rigid rules around definitions such as "inpatient" versus "outpatient" treatment create financial risk for hospitals introducing innovative treatment strategies. Furthermore, public ED workloads increase as GP consultation rates in older age groups decline, along with a reduction in GP bulk billing and availability after hours.13 Increasing indemnity insurance premiums for procedural GPs and private specialists also lead to greater public ED demand. Potential solutionsSystematic management of access block is only just beginning to be discussed at a policy level. The extent of the issue is now such that a more strategic Australia-wide approach is necessary. The experiences described in this issue of the Journal show that hospitals can improve their individual performance with organisational changes. But, despite the impressive changes achieved with the outlined approaches to access block, it is apparent that our healthcare system has serious underlying problems that need to be publicly acknowledged by politicians and appropriately addressed. Workforce: Historically, the major solution to hospital access issues was to spend money and increase bed numbers by employing more staff. Recently, in Victoria, money was allocated for increased bed numbers and services, but there were insufficient staff to open more beds (see the Royal Melbourne Hospital report, page 109). Reasons for rigidity in work practice and roles within the healthcare workforce need to be explored, and, where there is no evidence to support limitations in practice, rules should be changed. Universities, clinical colleges and hospitals must work together to train healthcare professionals for the tasks required rather than for roles based on historical models. Funding: The innovative practices described in the hospital experiences were partly enabled by incentives from federal, State/Territory and hospital initiatives. The funding method can help direct healthcare services toward community needs. For example, funding hospitals for procedures, whether provided on an inpatient or outpatient basis, might allow a hospital to provide those services even when beds are not available. Casemix payments tend to favour hospitals that provide uncomplicated elective services — perhaps alternative models that encourage healthcare services to look after elderly, complicated, medical patients should be trialled. Funding that allows a hospital to experiment with new clinical pathways and not be financially penalised, such as the National Demonstration Hospitals Project14 (aimed at improved hospital service efficiency and utilisation) and the Hospital Admission Risk Program15 (aimed at decreasing hospital bed utilisation), should be encouraged. The next round of Australian Health Care Agreements should ensure balance in financial incentives between elective and emergency services. There should also be recognition of the need to better remunerate GPs for providing complex care, perhaps involving a trial of a capitated payment or managed competition model.16 Healthcare delivery systems: The central message conveyed by the experiences described in this issue of the Journal is that changing internal processes can improve access to inpatient resources. Initiatives such as medihotels, placing patients in a transit lounge before discharge, day-of-surgery admission for elective surgery, short-stay wards, and centralised bed control can all save bed-days. Encouraging clinicians to trial treating patients in different ways and objectively analysing outcomes requires leadership from clinicians and administrators. For high-volume conditions and procedures, there should be standardised treatment pathways to expedite inpatient stay. Efficient use of beds also requires accurate, transparent data collection with rapid feedback to clinicians. Many hospitals are unable to accurately account for every patient and the purpose of their continued inpatient stay. Similarly, many hospitals do not have an accurate bed census that identifies the variability in the number of beds that are open from shift to shift, nor do all have the ability to accurately count nursing sick leave rates by shift and day of the week. Residential care: It is important that use of residential care facilities is tightly controlled and residents are allocated to the appropriate level of care. However, the current problem is that patients are unable to access long term residential care facilities and are instead filling acute care beds. Reform within the subacute and residential/community care sector is necessary to improve efficiencies within the acute care sector and to provide appropriate long term care to patients. Attention to more appropriate locations to care for the small group of long-stay patients is likely to be the most efficient strategy to improve patient flow through the subacute sector. Service prioritisation: The public must become involved in the debate about which healthcare services are essential. The present rationing method is in essence a lottery — whether your ambulance is allowed to arrive at a certain hospital, or whether your elective surgery is on or off, depends on the capricious availability of beds. The healthcare system cannot provide every service, but basic emergency and elective services could easily be provided within present budgetary constraints. A more transparent and educated debate may allow healthcare providers to work in a more satisfying environment where expectations are matched with necessary resources. There remains considerable pessimism about the ability of the acute healthcare sector to deliver an effective service in the face of increasing demand and limited resources. There are solutions. However, political leadership and a coordinated national approach are necessary to resolve underlying structural issues surrounding workforce, work practice and funding.

Peter A Cameron · Donald A Campbell

We need to derive absolute cardiovascular risk functions based on contemporary Australian data The accurate estimation of risk for future disease events is critical to the determination of the benefit–risk ratio and the most cost-effective use of preventive therapies (Box 1). This is particularly relevant for cardiovascular diseases (CVD), which are the leading cause of deaths in Australia (40% of total deaths), and in 1993–1994 accounted for the largest proportion (12%, or $3.9 billion) of total annual recurrent health expenditure.3 (This proportion is now almost certainly greater.) Expenditure on cardiovascular drugs under the Pharmaceutical Benefits Scheme totals $1.2 billion annually, $629 million of this on lipid-lowering drugs, especially statins.4 Accurate assessment of the likelihood of future events would optimise resource allocation by targeting patients at higher risk.5 In this context, the work of Simons et al, reported in this issue of the Journal (page 113),6 is very important. In their ongoing Dubbo Study (which commenced in 1988 and involved 2805 men and women aged 60 years and older when first assessed), the authors evaluated a risk function for coronary heart disease (CHD) prediction developed from a longitudinal cohort study in Framingham, Massachusetts — the Framingham Study. They also derived a risk function for future CVD events, including stroke as well as CHD, by modelling data from the Dubbo cohort. The Framingham risk functions7-9 are widely used and form the basis of a New Zealand cardiovascular risk calculator,10 itself proposed as the absolute risk measurement tool in the recent lipid guidelines of the National Heart Foundation/Cardiac Society of Australia and New Zealand.11 The Framingham cohort consists primarily of white, middle-class individuals. The equation was derived from calculations based on age, sex, cigarette smoking status, diabetes status, and blood pressure, cholesterol and HDL cholesterol levels only. The Framingham measurements were also made some time ago before the dramatic increase in the prevalence of diabetes,12 and indeed Framingham included low numbers of people with diabetes. In essence, the study by Simons et al determined the applicability of observations made in another time and another place to an Australian population. They showed that the Framingham equation accurately predicted overall 10-year incidence of "hard" CHD endpoints (myocardial infarction or coronary death). This supports previous validation work with the Framingham equation in the Busselton study.13 However, the Busselton study is now over 20 years old, while the Dubbo cohort included only older individuals. Therefore, while these validation studies are important, it would be more relevant to derive predictive equations from data obtained from a representative and contemporary Australian cohort. This would acknowledge the variety of ethnic groups in Australia and the current mix of known and unknown risk factors. As the Framingham equation correctly predicts risk in only about 80% of cases,14 there is considerable interest in "novel" risk factors (eg, high sensitivity C-reactive protein) and techniques for imaging the arterial wall. Future research must examine the degree to which these elements might improve the ability to correctly identify those at risk. With the shift of treatment guidelines from individual risk thresholds for treatment to decisions based on multivariable absolute risk, the logical extension of this is to estimate treatment efficacy or effectiveness in terms of absolute treatment benefit. For example, the benefits of cholesterol lowering in terms of improving average life expectancy have previously been estimated.15 This approach would provide more meaningful information to both patients and clinicians, as well as allowing the non-cardiovascular benefits of modifying risk factors such as tobacco smoking, physical inactivity, and unhealthy diet to be taken into account. Data such as those from the Dubbo study have important implications for current Australian guidelines and practice (Box 2). Treatment decisions based on individual risk-factor thresholds are inadequate. The Dubbo study assesses the validity of the Framingham risk prediction equations in the elderly and provides an Australian risk equation for the same age group. Further work should be done to validate these equations in a wider contemporary population and to determine the extent to which new risk factors may improve assessment of risk. This should not, however, preclude swift measures to implement the use of absolute risk, as well as consideration of absolute treatment benefit, as ways of guiding treatment decisions in clinical practice. 1: Why focus on absolute risk of cardiovascular disease? Individuals with levels which fall in the highest decile for systolic blood pressure, cholesterol and body mass index account for only 20%–30% of the total number of cases of stroke, ischaemic heart disease and diabetes.1 Interventions based on elevated levels of a single risk factor may allocate treatment to individuals with little chance of gain because of low absolute risk.2 Absolute risk is the likelihood of developing an event(s) over a particular time period. Absolute risk equations acknowledge the multifactorial causation of cardiovascular disease, the sex difference in risk and the steep increase in risk with ageing. Epidemiological studies have shown a continuum of risk for increasing levels of risk factors, such as blood pressure, total cholesterol and HDL cholesterol levels, which is acknowledged in absolute risk equations. 2: Recommendations for current guidelines, practice and research in cardiovascular disease Treatment guidelines should place greater emphasis on absolute risk estimation in those without manifest cardiovascular disease (CVD). Linking estimates of the likely absolute benefit of interventions with calculation of absolute risk should reinforce the rationale for lifestyle measure for all individuals and pharmacological treatment for those at higher risk. Prediction of overall CVD risk over 5 (or 10) years should be the endpoint, as opposed to risk of coronary heart disease alone. Components of a composite CVD endpoint should be re-examined and possibly restricted to "hard" outcomes such as CVD death, non-fatal myocardial infarction and non-fatal stroke. Agreement on and adoption of a standardised approach would facilitate implementing absolute risk prediction in Australia. Future studies should include variables that might further improve risk prediction (eg, waist circumference, microalbuminuria, high-sensitivity C-reactive protein). Absolute risk assessment is likely to be implemented most effectively using electronic tools which can link to other national initiatives. Absolute risk assessment will not only optimise health gains, but will result in more cost-effective treatment and prevention.

Andrew M Tonkin MB BS, MD, FRACP · Stephen S Lim BA, BSc · Henrik Schirmer MD, PhD

Assessing patients' spirituality provides important medical information In this issue of the Journal, Peach examines whether the medical profession in Australia ought to consider patients' religion or spirituality in clinical practice (page 86).1 There is much that Peach writes which I wholeheartedly support. This includes the important role that clergy play in medical settings, the need for further research on the health benefits (and risks) of spirituality in Australian patients, and the need to better understand the costs and benefits of Australian physicians making spiritual inquiries. However, on four points we disagree: Australians are not as religious as Americans and therefore religion is less important for Australian patients; although religion appears associated with health in the United States, there is little evidence for this in secularised Australia; assessing spirituality should probably be deferred to clergy or social workers; and until more is known, including spirituality in medical practice (in addition to addressing it in Australian medical schools) would be premature. Although Australians may be less religious than North Americans, the difference is not that great. Belief in God has decreased in Australia, but it has not gone away. In 1948, 95% believed in God; by 1975, the figure was 80%.2 In 1998, 74% believed in God, a higher spirit or life force,3 and according to the 1996 census only 0.05% of Australians are avowed atheists. When physical or emotional illness strikes, spiritual issues become even more important, as issues of meaning and purpose become relevant. This is particularly true for older adults with chronic illness, a population that will increase as Australians older than 65 years increase from 2.4 million people in 2001 to a projected 5.4 million in 2031.4 Even among younger patients, spiritual practices assume substantial importance. Consider a study of 108 patients (mean age 38 years) from medical practices in Sydney, in which researchers examined patients' experiences concerning the efficacy of 25 coping behaviours.5 Forty-one per cent of subjects indicated they would increase prayer in response to stress, 56% said prayer was helpful and, overall, prayer was ranked seventh in effectiveness, ahead of 18 other traditional coping behaviours, such as discussing the problem, seeking advice, spending time with friends, or socialising. Similar findings emerge among psychiatric patients. A study of 79 psychiatric patients at Broken Hill Base Hospital in New South Wales found that 79% rated spirituality as very important, 82% thought their therapist should be aware of their spiritual beliefs and needs, and 67% indicated that spirituality helped them cope with psychological pain.6 Thus, at least preliminary research suggests spiritual needs are not uncommon among Australian patients. Is religion related to better health in Australia? Although research is less plentiful than in the US, it is not entirely absent.7 Australian studies have found greater marital stability, less alcohol and illicit drug use, lower rates of and more negative attitudes toward suicide, less anxiety and depression, and greater altruism among the religious. Religiosity has also been associated with less cigarette smoking, more conservative sexual practices (reducing risk of sexually transmitted diseases), lower cortisol and catecholamine levels (for meditators), lower blood pressure, lower cholesterol, longer survival (Seventh Day Adventists), and even lower risk for colon cancer.8 Such findings are similar to those in the US,7 and, although more research is needed, these findings cannot be ignored. Because religion relates to health, and spiritual issues are important to many sick patients, deferring assessment of all such issues to clergy or social workers is probably unwise. Although physicians are not trained in this area, brief evaluation and orchestration of resources does not require great skills beyond what physicians already possess. Insufficient time is a problem, but it is not the main reason why physicians don't address spiritual issues. Rather, it is lack of comfort.9 Not knowing why or how to address such issues and feeling worried about imposing their beliefs on patients, not surprisingly they avoid the topic. Nevertheless, a brief spiritual history gathers information that is medically relevant and necessary to practice whole-person medicine.10 Are religious beliefs a source of comfort or stress in coping with illness? Does the patient have religious beliefs that could interfere or conflict with medical treatments? How might religious beliefs influence medical decision-making during serious or terminal illness? Is the patient part of a supportive faith community that can monitor and ensure compliance? Physicians also need to know their limits. If complex spiritual issues come up during assessment, then referral to trained clergy is appropriate and necessary. Physicians should not offer spiritual advice or counselling, or try to solve a patient's spiritual dilemmas. A patient who is not religious or does not wish to talk about such issues should not be pressed. Such inquiries must always be patient-centred, guided by the patient's wishes and religiosity, not the physician's. Nevertheless, taking a moment to listen, validate concerns, and mobilise spiritual resources are actions that physicians can do. Likewise, if the patient is a member of a faith community, then working with a parish nurse after discharge may ensure successful transition from hospital or medical office to home and community life.11 Exposing medical students in Australia to the role that religion plays in coping with illness and the research connecting religion and health should not be delayed. There is ample evidence to support some cautious first steps.12 Certainly, as Peach suggests, ongoing research is necessary. Nevertheless, religion is a powerful factor that can influence health, wellbeing, and medical decisions for better or worse. It should not be ignored or neglected by physicians.

Harold G Koenig M.D.