Volume 179 Issue 7

Referrals should be offered to all patients, and the individual needs of each patient considered Cardiac rehabilitation has progressed markedly since it was introduced into Australia by the National Heart Foundation in 1961. At that time, the focus was on restoration of a sense of wellbeing and encouraging return to work for survivors of acute myocardial infarction and other cardiac illness. The first cardiac rehabilitation programs in Europe and the United States involved mainly supervised, high-intensity exercise training with electrocardiographic monitoring. As data accumulated that similar benefits could be achieved from low, moderate and high levels of exercise intensity,1,2 an Australian hospital model evolved, based on group light exercise and patient education.3 Recognition that psychosocial factors (rather than heart disease) were the main causes of disability after a myocardial infarction led to greater emphasis on counselling, education and support. This led, in turn, to the development of a multidisciplinary team approach to cardiac rehabilitation, with the aim of focusing on and dealing with the range of factors influencing patients’ quality of life. As evidence from large clinical trials emerged showing that modifying risk factors through both pharmacological interventions and lifestyle change could significantly reduce mortality and morbidity, the aims of cardiac rehabilitation broadened to include preventing progression of cardiovascular disease. . . . a majority of eligible Australians are failing to achieve the potential gains available from our network of outpatient cardiac rehabilitation programs. By 1986, cardiac rehabilitation had advanced sufficiently for it to be seen as an important component of cardiac care. Dr William A Seldon, a cardiologist at St Vincent’s Hospital, Sydney, and the first Director of the National Heart Foundation Cardiac Rehabilitation Centre in Sydney, wrote in the Journal: It is not difficult to envisage that a failure to provide cardiac rehabilitation services to patients with myocardial infarction will be regarded as medical negligence in the not too distant future.4 Since then, there has been a progressive increase in the provision of such services throughout Australia. The National Heart Foundation’s 2001 Directory of Australian cardiac rehabilitation programs5 lists 265 hospital- and community-based out-patient programs, compared with only 26 in 1985.6 The growth and development of these programs in Australia over the past two decades has occurred alongside the publication of several evidence-based guidelines summarising the benefits of structured cardiac rehabilitation and secondary prevention programs.7-9 Defined benefits include reduced mortality and reduced risk of further cardiac events; improvements in physical and social functioning, risk factor profiles and quality of life; and reduced prevalence of depression. Despite the convincing evidence and the increased availability of cardiac rehabilitation programs, the report by Scott et al10 in this issue of the Journal (page 341) highlights suboptimal rates of referral to and utilisation of outpatient cardiac rehabilitation programs in Queensland: 29% of patients with cardiac diagnoses discharged from participating hospitals were referred to an outpatient cardiac rehabilitation program, while 49% of discharged patients were eligible for such a referral. Fewer than a third of patients referred completed the program. It was estimated that only 40% of available outpatient cardiac rehabilitation program places were fully utilised. Similarly, a study of data from the NSW Hunter Region Heart and Stroke Register11 identified that only 39% of the patients on the register who were eligible for outpatient cardiac rehabilitation were invited to attend. This figure is likely to be an overestimate, as only 62% of all discharged patients consented to be on the register. It is clear that a majority of eligible Australians are failing to achieve the potential gains available from our network of outpatient cardiac rehabilitation programs. This distressing failure reflects both a lack of initial referrals and a failure of patients to attend, despite having been referred. Key factors contributing to these deficiencies include the following: data have not been collected to establish cardiovascular health indicators for monitoring the proportion of patients entering and completing a cardiac rehabilitation program;12 routine referral, although recommended in Australia,8 is not standard practice; cardiac rehabilitation programs are not available or accessible to all patients, especially those in rural and remote areas;12 and cardiac rehabilitation programs are not sufficiently accessible and attractive to certain population groups, such as Indigenous people, older women, those unable to speak English, and the indigent.12 What strategies can be implemented to address these issues? System factors resulting in failure of referral should be investigated and rectified. It is well known that discharge planning and linkages between hospitals and primary care services are often poor or non-existent. In addition, the attitude of the treating physician is a major predictor of patient non-participation in cardiac rehabilitation.13 Scott et al found that patients having coronary revascularisation procedures were more likely to attend rehabilitation programs than those with acute coronary syndromes.10 Is it that some patients perceive a greater need for rehabilitation programs as part of the recovery process and that this need is also appreciated by their key healthcare providers? Patient “denial” of severity of illness and a history of depression have both been found to be significant predictors of participation,13 and may also account for the varying participation rates by diagnosis or procedure. Patient preferences for different program models and methods of delivery should be canvassed. Referrals should be offered to all patients, and the individual needs of each patient considered. Medical practitioners and healthcare authorities need to understand and accept that not all patients’ needs can be met by so-called “usual” medical care.

Stephen J Bunker PhD, RN · Alan J Goble MD, FRACP, FRCP

Has enthusiasm overwhelmed judgement? Although advocates of the use of tissue plasminogen activator (tPA) in acute ischaemic stroke suggest that this “is one of the most important advances in stroke medicine”,1 a recent Cochrane meta-analysis also supports “clinicians who choose . . . not to use the treatment at all”,2 and all three major emergency medicine associations in North America have declined to endorse it as “standard of care”.3 In a recent issue of the Journal, Szoeke and colleagues’ audit of tPA use in a tertiary-care hospital concluded that “favourable outcomes . . . were similar to those achieved in international . . . trials in specialised centres”,4 while an accompanying editorial highlighted that “the absolute benefits of stroke care unit management clearly outweigh those of . . . tPA administration”.1 Several letters in this issue of the Journal raise important concerns about the report of Szoeke et al, as well as the overall risks and benefits of the use of tPA in ischaemic stroke (page 386).5-7 A single dose of aspirin provides benefit to about 15 times as many stroke patients as does tPA,1 at far less risk. This is true even assuming tPA benefits one in every eight patients treated, which is based on a point estimate taken from the National Institute of Neurological Diseases and Stroke (NINDS) trial,8 the only randomised controlled trial which found a benefit for its primary endpoint. This does not take into account the wide confidence intervals in the NINDS trial, the negative results of multiple other randomised controlled trials,9,10 and the far worse results in non-expert hands. Even under a “maximum benefit” scenario, with further assumptions that overestimate the impact of tPA (including that it could be given safely and effectively to 10% of acute stroke patients, rather than the 1%–3% non-protocol-violation treatments in typical community studies),11,12 tPA would have only minimally greater impact than aspirin. Ultimately, regardless of who is correct about the available evidence, the overall impact of tPA in acute ischaemic stroke is at most marginal, which makes it difficult to understand why “so much has been made of so little”.7 Perhaps it has to do with enthusiasm for what is frequently called the “first treatment for stroke”, although, as noted, there are far more important (but far less dramatic) treatments available. Readers will have to decide for themselves whether it also has something to do with money,3 or if this is truly “extending conspiracy theory to its limits”, as Donnan and colleagues claim (page 388).13 Previous critiques of the use of tPA in ischaemic stroke have raised the following issues: There is a paucity of positive evidence; all but one small randomised controlled trial failed to find benefit in the primary outcome, or found substantial harm.14,15 Even in the NINDS trial, the benefit was primarily in patients treated less than 90 minutes after symptom onset16 (almost no such patients exist in actual community practice), so the number needed to treat in the 91–180-minute group is surely far higher than the “eight patients needed to treat” widely quoted. “Effectiveness” in a community setting is far different from “efficacy” as reported in the NINDS trial (even if NINDS is taken at face value).15,16 Let me add the following observations. Most supporters of tPA claim that three trials involving streptokinase are irrelevant (including one done in Australia, with very negative results10). However, in the absence of studies directly comparing them, there is no reason to believe that tPA should be better than streptokinase for treating ischaemic stroke. In head-to-head cardiac megatrials (ISIS III, GISSI II, and GUSTO I), tPA consistently caused more intracerebral haemorrhage than streptokinase, which is likely to be even more important in patients with stroke. Furthermore, the GUSTO I trial, which provided the only remotely credible (albeit controversial) evidence suggesting tPA might be a bit more effective than streptokinase in coronary patients, was explicitly based on the notion that adjunctive intravenous heparin must be given with tPA — an approach contraindicated in stroke. Excluding streptokinase trials from the analysis of thrombolytics in stroke because they happened to be negative is simply inappropriate. Although Szoeke et al’s report is not strictly an “efficacy” study, neither is it a community practice “effectiveness” study, as treatment was by experts in a tertiary care facility. Thus, in no case should the results be extrapolated to other practice environments. Furthermore, it is critical to note the report’s limitations: Most obviously, there were no randomised controls, and outcomes were measured unblinded to the use of tPA, creating enormous potential for measurement bias. The study failed to meet most of the methodological criteria considered critical for chart reviews17 (eg, use of trained abstractors [ideally other than the authors], standardised abstraction forms and multiple independent reviewers for at least some of the charts, with some measure of agreement between reviewers; use of explicit criteria for coding of outcomes and explicit definitions for interpreting absent or inconsistent data). Outcomes among 30 patients receiving tPA may have been “consistent with” the NINDS result, but, given the small numbers and extremely wide confidence intervals, were also consistent with virtually any result. The report may well represent publication bias. Indeed, the most positive “effectiveness” study reported results from 57 of 83 centres that participated in a proprietary randomised controlled trial18 — what happened to the other 26? The only two reports that included all patients receiving tPA in a given community each documented unacceptable outcomes.11,12 Finally, there is the problem of interpretation bias. Szoeke et al classified one of the deaths after tPA therapy as a protocol violation, which will allow advocates to claim the results “would have been even better if . . .”. But this was based on an exclusion criterion that was not part of the NINDS protocol (ie, “early signs on computed tomography [CT] suggesting infarct of more than a third of the territory of the middle cerebral artery”), and despite the fact that the study’s expert CT readers did not agree whether this patient even met that criterion! This example (out of many) should provide insight into the way the “spin” of enthusiastic authors can lead to conclusions that are rosier than results actually justify. Many of us believe that thrombolytic therapy in stroke remains far from proven, so that its use should be restricted to further randomised controlled trials. This would not only enable us to determine whether this therapy produces more good than harm, or vice versa, but might also allow identification of subgroups in whom it is, or is not, indicated. We could then avoid giving a potentially fatal drug to a patient in whom it increases risk unacceptably, while also allowing current sceptics to use it in a different patient likely to benefit — assuming such patients, in either category, could be identified. If tPA use becomes more widespread, a very small number of patients may receive great personal benefit, while a very few others may be subjected to great personal harm. However, the broader implications of this debate are substantial. Modern health policy traditionally rests on the “precautionary principle”, which requires that no new practice be widely introduced until it is shown to be safe. This principle is under fierce attack in postmodern society by advocates of the contrary “Kehoe principle”, which asserts that if something may have value it should be accepted unless it’s proven dangerous.19 It is, of course, almost impossible to prove such danger, and, once approval is given, it may take many years — and a great deal of harm — before the decision can be reversed. Such was the case with leaded gasoline, which was termed “a gift of God” by its discoverer, Robert Kehoe, after whom this dangerous principle is named,19 and which was used ubiquitously for over 60 years, despite widespread understanding of its terrible public health impact. Whether or not the medical community insists on real evidence that tPA will do more good than harm in acute ischaemic stroke will also reflect how we feel about the introduction of all manner of potentially beneficial, but also potentially dangerous, new treatments.

Jerome R Hoffman MA, MD

A new model of depression with meaningful subtypes will avoid simplistic treatments When you hear the term “major depression”, you imagine a clinically meaningful entity. Think “pseudoentity”, know “paradigm failure”.1 If I took my tegument for dermatological inspection, a diagnosis of “major” or “minor” blotches would be uninformative. I would need more categorical information (eg, freckle, melanoma) to make rational treatment choices. However, non-specificity now rules in depression modelling and treatment. “Depression” is currently viewed as a single disorder, varying dimensionally. The World Health Organization’s international classification of diseases, 10th revision (ICD-10), specifies “mild”, “moderate” and “severe” episodes.2 The US Diagnostic and statistical manual of mental disorders, 4th edition (DSM-IV)3 categorises depression as “major depression” (episodes requiring at least five symptoms present for two weeks) and other (including “minor”) disorders. The Plimsoll line for “caseness” (ie, for diagnosis of a depressive disorder) has been further lowered, with two or more depressive symptoms held to define “new” (“subsyndromal” or “subclinical”) mood disorders.4 If the criteria for caseness are progressively loosened so as to capture most of the “blue” population, isn’t the meaning of a “depressive disorder” lost? The logical inconsistency of positing a “subclinical” disorder as a clinical disorder has not, however, discouraged efforts to prove high prevalence, functional impairment and need for treatment. The dominant Zeitgeist views depression as an “it”, a disease having nothing to do with the individual’s personality, and, because “it” is caused by chemical brain changes, requiring an antidepressant drug. However, for those with an antipathy to antidepressants, there are equally effective psychotherapies. Thus, all roads lead to Rome. Such “homogenising” has resulted in efficacy studies (the largest database in psychiatry) producing quite meaningless results.5 “Evidence-based psychiatry” is at risk of becoming an oxymoron. Mere polemic? Let’s consider some data. For “major depression”, efficacy studies quantify all antidepressants (old and new classes compared between and within classes) as equally efficacious,6 and the overall antidepressant drug response as comparable to that for St John’s wort, cognitive behaviour therapy (CBT), other psychotherapies and counselling.5 Why? Data from efficacy studies submitted by pharmaceutical companies for product licensing are problematic. One analysis of data for antidepressants submitted to the US Food and Drug Administration (FDA) showed that, of 47 trials for major depression, there was no drug effect in nine, and a drug–placebo difference of questionable significance for the remainder.7 In another analysis of 52 pivotal placebo-controlled FDA-submitted studies,8 half showed no advantage to the antidepressant drug. “Homogenising” depression and implying “universal” application for treatments leads to the inability to distinguish between differing effects according to differing depressive subtypes. Furthermore, trial selection of pristine subjects (eg, those without comorbidity, in whom melancholic depression is rare) ensures a high response rate in trials (to both active treatment and placebo) and thus their minimal separation. Yet these are the data on which current practice and treatment guidelines are based.9 So, everyone’s a winner — and a loser. Winners? All therapies can claim efficacy. Treatment then risks being determined more by the therapist’s discipline or interest — a Procrustean approach that fits the patient to the therapist’s preferred treatment. Losers? The pharmaceutical companies are challenged for “overselling” the properties of antidepressant drugs, patients feel demeaned in reading that antidepressant drugs are akin to placebos, and practitioner credibility is challenged. Moving along the “overselling” dimension, we are informed that the benefits of CBT have been scientifically proven and that it is the benchmark non-drug therapy. While CBT has credibility, a recent review10 of its efficacy returned the Scottish verdict of “not proven”, in that it lacked any superiority over other psychotherapies or “clinical management”. Despite CBT being held to be useful for multiple psychosocial problems, a recent Cochrane review11 of psychosocial interventions delivered in general practice found “good evidence that problem-solving treatment by general practitioners is effective for major depression”, but limited or conflicting evidence for CBT. As for antidepressant drugs, a potentially useful treatment may “fail” or appear weak if it is not tested on people with subtypes of depression who are likely to benefit. Let’s broaden the argument. Would we be sanguine about grouping all breast lumps (ranging from benign cysts to malignant cancers), testing myriad treatments as universal ones, interpreting the “homogenised” group data as indicative of comparable efficacy, and having an individual’s treatment determined largely by the treating practitioner’s discipline or enthusiasm? We would surely expect that a subtyping diagnosis would be made and that any treatment would be empirically based. Such a standard should also be demanded for diagnosing and managing the depressive disorders. While it is important that the mood disorders be destigmatised and that people be encouraged to seek assessment, it is equally important that they then receive appropriate diagnosis and treatment. Unpublished data from our clinics suggest that bipolar disorder is often missed or misdiagnosed, that the more biological (“black”) depressive disorders are undertreated, and that there is too much reliance on pharmacological treatments for managing non-melancholic disorders. We favour a model for identifying meaningful depressive subtypes that incorporates aetiology, development of a matrix linking subtypes to specific (and non-specific) treatments, testing the model’s utility in “real-world” clinical studies, and promoting broader education of professionals. The model is not intrinsically complex. The complexity lies in recognising and changing the Zeitgeist (see Box). While there is an argument for destigmatising depression with a simple message, there is no argument for doctors continuing to buy simplistic “one-size-fits-all” management recommendations for patients who present for assessment. Recommendations Treatment guidelines for managing the depressive disorders that rely on efficacy data should be regarded as providing tentative information at best. There is no “universal treatment” for depression. As it encompasses mood disturbances, syndromes, disorders and diseases, clinicians should expect heterogeneity, resist simplification, and reject the plausibility of any “universal treatment” model. Clinicians should seek to identify and address the causes of an individual’s disorder, allowing that causes may be biological, psychological and/or social. Assessing disorder “pattern” and aetiology (as against depression severity) allows clarification of the differential impact of various treatments on different disorder “types”. Clinical effectiveness data (assessing the full range of mood disorders and associated comorbidity in “real-world” conditions) should be given more airtime in developing a disorder–treatment matrix.

Gordon B Parker DSc MD PhD

It’s time to stop applying bandaids and get on with real change Despite their protests that it was a “hold-up” and that it “may tragically be the death warrant for some people”,1 last month our state premiers capitulated and signed the 2003–2008 Australian Health Care Agreements (AHCAs). Since then, the healthcare crisis has all but disappeared from the front pages of newspapers and television screens, but, for the community, the crisis remains a daily reality. The desire for healthcare reform, so evident at the recent Australian Health Care Summit,2 will continue, and the demand for the AHCA’s reform blueprint3 to be implemented will only increase in the face of the ongoing inertia of our health ministers. In short, there is now widespread expectation of less political rhetoric and more action. However, sustainable reform requires a change in the political and professional landscape of Australian healthcare. In a keynote address at the Australian Health Care Summit, leading health reform expert John Menadue diagnosed the ailments of our healthcare system, and proffered some cures. His address, Healthcare reform: possible ways forward, appears in this issue of the Journal (page 367)4 as the first in a series of selected addresses to the Summit. Menadue’s diagnostic skill comes from his role in promoting healthcare reform as chair of the New South Wales Health Council,5 and, more recently, as chair of the South Australian Generational Health Review.6 It would seem that Australia’s healthcare system is not at all well. In the upper echelons of healthcare, Menadue has identified a multitude of ailments, including: endemic political buck-passing across jurisdictional divides; lack of public honesty by governments as to what the healthcare system can provide given its limited funding; and a preoccupation on the part of health ministers and their advisers with media management and health micromanagement, much to the detriment of more significant healthcare issues. In essence, our health system is overpoliticised. Short electoral cycles, constant ministerial turnover and the body politic’s demand for instant solutions are not compatible with reforming a large and complex system.7 At a middle level the ailments include: isolated healthcare professionals who run insider debates with little involvement of the community; a system that is hospital-centred at the expense of primary care, population health and community-based care; and a pervading executive ethos of decision paralysis. Menadue’s diagnosis of Australian healthcare is that it is institutionalised, introverted, and wary of innovation and change — a system constantly crying out for “more money please”.4 However, all is not doom and gloom. Menadue also offers possible cures. Most prominent among these is to have Commonwealth and state governments involve the community in setting priorities in healthcare spending. After all, it is about their health and their tax dollars! Reform means change, and change is always difficult to achieve, but a real life example of healthcare reform and change management has been in train in NSW since 1999 (see Box). In that year, the then NSW Minister for Health, Craig Knowles, initiated a major review of the state’s health system by two independent bodies comprising health and other experts, consumer representatives, and headed by prominent individuals from outside the health system. After an extensive and consultative process, the overarching recommendations from one of these bodies, the NSW Health Council, were the need for metropolitan-wide planning of clinical services (including the role of district hospitals in clinical networks) and increased engagement of senior clinicians in planning and administering health services.5 The NSW government promptly accepted the major thrust of the report, and the health minister initiated a cascade of processes to improve healthcare delivery in the greater metropolitan region (see Box).8 The change process is driven by the Greater Metropolitan Transition Taskforce (GMTT), an independent external body established to monitor progress and facilitate progress (see Box). The principles for achieving reform and managing change evident in this NSW experience include: a health minister with vision and political clout; use of respected outsiders to lead independent bodies in exploring frameworks for reform through extensive and inclusive consultation; timely acceptance of major recommendations by the government; delegating implementation of change and progress monitoring to an independent body, outside the bureaucratic stream, but with “buy in” of professional expertise; and, most importantly, giving “experts” the freedom and time to achieve the task. Overriding all of this, however, is the need for a collective political will for meaningful reform. The AHCAs have been signed and our health ministers have an interlude of no more than 4 years. Over a year ago, all our health ministers agreed on an agenda of reform and change.10 If there is no meaningful movement within the next year or so, patients, doctors, nurses and other health professionals have every right to say “a plague on both your houses”.11 Healthcare reform in New South Wales July 1999: The NSW health minister initiated an extensive independent review of the NSW healthcare system which included establishing the NSW Health Council to examine the way the NSW healthcare system delivers care. March 2000: The NSW Health Council recommended developing a single, coherent, long-term, organised plan for metropolitan Sydney.5 May 2000: The Greater Metropolitan Services Implementation Group (GMSIG) was convened by the health minister to examine hospital services. June 2001: GMSIG report, incorporating 162 recommendations related to a broad range of acute hospital services,8 was accepted as NSW government policy. November 2001: Health minister established the Greater Metropolitan Transition Taskforce (GMTT) to implement the GMSIG recommendations, specifically to examine hospital services in the greater metropolitan region, including Sydney, the Central Coast, Hunter and Illawarra. July 2002: $64.5 million annual recurrent enhancement funding ($30.9m to the 22 smaller “District” metropolitan hospitals) targeted to areas that clinicians considered the highest priority.9 December 2003: GMTT to report on achievements in 15 clinical program areas identified by GMSIG and seven additional clinical programs reviewed at the request of clinicians. GMTT convened working groups across these 22 specialty areas, and held open meetings at hospitals across the greater metropolitan region. Over 2000 doctors, nurses, allied health professionals and consumers were involved in the working groups. Selected outcomes to date Establishment of collegiate approach between doctors, nurses, allied healthcare professionals and consumers, and of clinical networks to coordinate services. Sustainable clinical governance with consumer involvement established in 24 hospital disciplines in the greater metropolitan region. 300 new clinical positions established in metropolitan hospitals; 19 stroke units with common treatment protocols established; three new cardiac units established on the periphery of the metropolitan area to provide cardiac angiography; five computed tomography scanners and staff provided; and interhospital transport upgraded. Statewide services coordinated in severe burns, spinal cord injury, brain injury rehabilitation and major trauma.

Martin B Van Der Weyden MD, FRACP, FRCPA

Objectives: To determine patient participation rates in outpatient cardiac rehabilitation (OCR) programs; ascertain the barriers to participation; and evaluate the quality of OCR programs. Design and setting: Retrospective cohort study of patient separations from selected public and private Queensland hospitals; questionnaire survey of hospitals and all registered OCR programs. Participants: Patients discharged with cardiac diagnoses between 1 July 1999 and 30 June 2000 from 31 hospitals (24 public; 7 private). Main outcome measures: Rates of referral of hospitalised patients to OCR programs; rates of program attendance and completion; barriers to OCR referral and attendance. Results: 15 186 patients were discharged with cardiac diagnoses from participating hospitals, of whom 4346 (29%) were referred to an OCR program after discharge, compared with an estimated 59% (8895/15 186) of patients who were eligible for such a program. Proportionately more patients were referred from secondary (38% [1720/4500]) and private (52% [2116/4031]; P < 0.001) hospitals than from tertiary (25% [2626/10 686]) and public (20% [2230/11 155]) hospitals. Patients undergoing coronary revascularisation procedures comprised 35% of discharges, but accounted for 56% of all program attendances. Fewer than a third of all referred patients completed OCR programs, and only 39% of available OCR program places were fully utilised. Catchment populations of programs with unused places had excess coronary mortality. Conclusion: There is significant underutilisation of facility-based OCR programs in Queensland. Procedures are required for identifying and referring eligible patients to existing programs and improving program compliance. Alternative OCR models are also required.

Ian A Scott FRACP, MHA, MEd · Kylie A Lindsay BN, GradCertManag · Hazel E Harden BSc

Objective: To determine the prevalence of iodine deficiency in primary school children in an Australian urban population.Design and setting: A cross-sectional survey of school children aged 5–13 years attending a public school on the Central Coast of New South Wales in November 2000.Participants: 324 (70%) of the 465 children enrolled in the school (180 boys; 144 girls).Main outcome measures: Thyroid volumes compared with World Health Organization/International Council for the Control of Iodine Deficiency Disorders (WHO/ICCIDD) thyroid volume reference values. Iodine status based on WHO/ICCIDD urinary iodine concentration (UIC) categories (normal, ≥ 100 μg per litre of urine [μg/L]; mild iodine deficiency, 50–99 μg/L; moderate deficiency, 20–49 μg/L; severe deficiency, < 20 μg/L); not more than 20% of the population should have a UIC below 50 μg/L.Results: Median UIC for school children was 82 μg/L, and 14% of children had UICs below 50 μg/L. Thyroid volume reference values indicated a prevalence of goitre of zero. In girls, only four (3%) and one (1%) had thyroid volumes above the WHO/ICCIDD medians by age and body surface area (BSA), respectively (P < 0.001). In boys, three (2%) and one (1%) had thyroid volumes above WHO/ICCIDD medians by age and BSA, respectively (P < 0.001).Conclusion: Despite the median UIC being less than ideal, most children were not goitrous. This underscores the importance of using physiological outcome measures in areas where iodine deficiency is marginal before concluding the need for iodine supplementation based purely on median UIC. We call for a systematic national survey to determine iodine status using a combination of iodine deficiency indicators.

Kamala Guttikonda MB BS, FRACP · Steven Boyages FRACP, PhD · Cheryl A Travers BSc · Peter R Lewis MB BS, FAFPHM

Objectives: To investigate the effectiveness of telephone counselling as an adjunct to nicotine replacement therapy (NRT) by transdermal patch in smoking cessation.Design: Randomised controlled trial.Participants and setting: 854 smokers from New South Wales, aged 18 years and older, who had smoked at least 10 cigarettes per day for the past year and responded to newspaper advertisements between October 2001 and January 2002; the trial was conducted between October 2001 and August 2002.Interventions: Random allocation to either NRT alone or NRT plus telephone counselling (5 sessions spaced according to a relapse-sensitive call schedule).Main outcome measures: Self-reported abstinence assessed by telephone questionnaires at 1, 2, 3 and 6 months: 28-day continuous abstinence at 3 and 6 months, and 90-day continuous abstinence at 6 months.Results: 28-day continuous abstinence rates among participants receiving telephone counselling were significantly greater than among those not receiving telephone counselling at both 3 and 6 months (31.6% v 25.1%; P = 0.04 at 3 months; and 30.1% v 22.4%; P = 0.01 at 6 months). Similarly, 90-day continuous abstinence rates at 6 months were significantly greater for participants receiving counselling (26.7% v 18.6%; P = 0.004).Conclusion: Telephone counselling as an adjunct to NRT increases abstinence rates beyond the use of NRT alone.

Zane R Macleod BA(Hons), MPsych, MAPS · Veronica C Arnaldi · Ian M Adams BSc(Hons), MSc, MBA · Margaret A Charles BA, PhD, MAPS

After the Bali bombing on 12 October 2002, many injured Australians required evacuation to Darwin, and then to burns units around Australia. Many patients were evacuated from Denpasar by Qantas, with assistance from staff of civilian medical retrieval services. The transport of patients from Darwin to specialist burns units involved a coordinated response of civilian and military services. Some issues in responding to such disasters were identified, and a national coordinating network could improve future responses. On Saturday evening, 12 October 2002, two bombs exploded in a crowded nightclub area at Kuta Beach, Bali. The explosions killed more than 180 people and injured several hundred others. Injuries were principally burns and shrapnel injuries. Local healthcare resources, which do not include a specialist burns capability, were rapidly overwhelmed. Many of the injured were Australian citizens, who required evacuation to Australia. The military response has been described previously.1 Civilian evacuation flights directly from BaliActivationEarly in the morning of Sunday, 13 October, Qantas Security asked Qantas medical staff to organise a medical team to fly to Bali to assist in evacuating injured people. Two doctors and three nurses, medical equipment from Qantas Aviation Health Services, and several members of Qantas Security travelled to Bali on a Boeing 767, departing Sydney at 17:00 EST on Sunday. During the day, NSW Health and the Medical Retrieval Unit of the Ambulance Service of New South Wales offered medical teams to fly to Bali to care for any patients who presented at the airport with injuries. Thus a team of four doctors and two paramedics drawn from CareFlight and the Sydney Aeromedical Retrieval Service was dispatched on a second Qantas Boeing 767 flight at 18:00. A consignment of medical equipment, including a large quantity of burns dressings, analgesic and intravenous fluids, was also transported. When the first aircraft arrived in Denpasar, hundreds of passengers were queued at check-in, many with obvious burns and shrapnel injuries. A treatment area was set up within the departure lounge, and triage commenced. The medical personnel began cleaning and dressing wounds for people departing on the first flight to Sydney. The arrival of the second aircraft provided additional resources, and enabled medical personnel to accompany each Qantas flight that departed Denpasar. First Qantas flight from Denpasar to SydneyTriageAs soon as they arrived in Bali, a doctor and paramedic team from CareFlight transferred to the first aircraft, which was ready for departure. This team walked around the cabin with a flight attendant to estimate the number of injured passengers and the type of injuries. This initial assessment guided the decision on what equipment was to be taken on the flight, and what was to be left for subsequent flights. After take-off, patients were triaged using the Homebush triage taxonomy2 (Red, Immediate; Yellow, Urgent; Green, Not Urgent) and the CareFlight triage algorithm.3 Although appropriately coloured tags were available, they were not used to indicate patient priority. Instead, they were positioned so that they protruded from the top of patients’ seats, simply indicating the location of an injured passenger in the cabin. About 20 passengers who would require treatment were identified. To facilitate assessment, treatment, and observation, the cabin crew seated the injured passengers together. The pilot’s rest cabin was used as a treatment room. Although narrow, the cabin has a recliner seat that allowed semi-supine positioning of patients, and the door provided privacy. The doctor assessed individual patients, documenting injuries on the triage tag, and treatment to be instituted in flight. One of the uninjured passengers was a medical colleague of the treating doctor, and volunteered to assist, providing invaluable assistance in assessing patients and obtaining intravenous access. As expected, given that the passengers were ambulant and had boarded by themselves, no critically injured patients were identified. Therefore, the triage system was modified to reflect the order of medical attention. Red priority was allocated to patients with burns, dehydration or multiple injuries, and those in severe pain. Yellow priority was allocated to stable patients with injuries that might deteriorate. Green priority was allocated to patients with emotional disturbance or minor injuries. TreatmentAll patients with burns were re-examined to obtain accurate estimates of burn area and intravenous fluid requirements. Those with significant burns (20%–30%) were managed with moist burn dressings, intravenous fluid therapy, and intravenous analgesia. The injuries (Box 1) were consistent with previous reports from terrorist bombings,4-6 but generally less severe, as the patients were ambulant. The patient with a depressed skull fracture had no neurological deficit and remained stable for the duration of the flight. Equipment was available to enable intubation, ventilation and administration of osmotic agents if the patient’s condition had deteriorated. The most common interventions were bandages, dressings and intravenous fluid. Giving sets for intravenous fluids were hung from overhead luggage bins with hooks made from coat hangers. The requirements for analgesics and anxiolytics were less than expected; many people were prepared to tolerate significant pain knowing they were safe and on their way home. Morphine supplies had been left in Denpasar, so ketamine was used to provide analgesia during the flight. Unlike morphine, ketamine does not cause respiratory depression, an important consideration in a commercial aircraft, where the high altitude and resulting low cabin pressure render passengers relatively hypoxic. Although the dose was kept to less than 0.5mg/kg, some patients experienced transient dysphoric effects. On arrival at Sydney (Kingsford-Smith) Airport, the aircraft were met by ambulance and medical personnel. Passengers with minor injuries were asked to refer themselves for further assessment to the medical teams at the airport or to their local hospitals and general practitioners. Subsequent flights from DenpasarWhen the second flight back to Sydney was ready for boarding, a doctor and paramedic did a quick walk-through of the area where passengers waited. As there were no severely injured people, the paramedic alone accompanied the flight back to Sydney. During transit, about 25 patients were identified with injuries, including minor burns and shrapnel wounds. The medical personnel who remained in Denpasar screened passengers for the subsequent flights. A doctor was positioned at the check-in line. Many passengers attempted to conceal injuries, believing that they would be refused transport if their injuries were identified. Passengers with injuries were more readily identifiable when walking, as limps, bandages, slings, and undressed wounds were more difficult to conceal. These passengers, who required reassurance that they would still be allowed to travel, were asked to go to the treatment area. About 55 passengers who required medical interventions were identified in this way. These passengers principally required analgesia and wound dressings, and boarded subsequent flights. A further five Sydney Aeromedical Retrieval Service doctors and paramedics were dispatched from Sydney on the Monday evening, allowing all additional flights to return to Sydney with medical personnel on board. In total, Qantas operated nine special evacuation flights, returning more than 4500 people to Australia. More than 2000 kg of medical supplies were also carried. The response in DarwinThe most severely injured patients repatriated to Australia were evacuated from Bali on five Hercules C-130 military transport aircraft.1 These flights transported 65 patients to Royal Darwin Hospital (RDH) for stabilisation and initial surgery. Fifty-three of these patients were listed as serious or critical. The RDH disaster plan, which had revealed no operational deficiencies when recently tested for the East Timor conflict, was activated 16 hours before the arrival of the first C-130, allowing the intensive care unit, emergency department and an entire surgical floor to be essentially emptied and prepared. Many RDH staff volunteered for duty, and resources were pooled from the adjacent private hospital. At 15:00 CST on Sunday, 13 October, the Commonwealth Department of Health and Ageing accepted an offer from the Royal Adelaide Hospital (RAH) of 10 staff to complement the resources of the RDH. The RAH teams (a burns surgical team of three, a critical care medical team of five doctors, and two critical care retrieval nurses) reached Darwin before the arrival of the first C-130 carrying injured patients at 01:30 on Monday. The most senior burns surgeon and the critical care teams were initially placed at Darwin airport. The patients, especially on the first C-130, had had minimal resuscitation only and were retriaged at Darwin airport by a four-person medical team comprising an RDH anaesthetist, an RAH intensivist, the RAH burns surgeon and a doctor from the Australian Defence Force (ADF). Although only three patients on the first two C-130s were intubated, within a few hours of arriving at RDH many others required intubation and other critical care support. Patients were probably protected from airway swelling by the lack of fluid resuscitation provided in Bali and on the flight to Darwin. When effective fluid resuscitation was initiated at RDH, airway swelling and other problems became apparent, necessitating admission to the intensive care unit. The RAH staff assisted in the RDH intensive care unit, performing complex intubations and central line insertions, as well as more than 100 burns surgical procedures. Secondary transports from DarwinRDH does not have a burns unit or the capability to provide ongoing management for large numbers of severely injured patients, so, after the second C-130 arrived, a request was made to Emergency Management Australia, the federal organisation responsible for disaster coordination, training and research, for patients to be transported from RDH. Two critical patients were transported directly from Darwin Airport to RAH, after being assessed and stabilised at the airport before the 4-hour flight. Most of the secondary aeromedical evacuations occurred over the next 24 hours, although they continued intermittently for 5 days. The critical care patients could only be transported one or two to a plane, as medically equipped civilian aircraft do not have the capacity of the military aircraft. A summary of the critical care aeromedical evacuations from Darwin is included in Box 2. Box 3 shows a team preparing a patient for transport. Patients were allocated to destinations on the basis of their stability when transport was available, their home state, and a desire to distribute unstabilised patients between aircraft. Seventeen critical patients were evacuated from Darwin, although many who were categorised as serious would have been classed as critical in normal circumstances. RAH, RDH and ADF staff worked together to coordinate the use of civilian and military aircraft to transport the 17 critical and 37 serious patients to burns units in other states. Civilian–military coordination was facilitated by two RAH staff who held dual military and civilian positions. This enabled changes in transport allocation for a number of patients as their condition changed during Monday afternoon and evening. Improving the response for future disastersAlthough the ADF bore the major responsibility for evacuating victims of the bombing from hospitals in Denpasar to Darwin, most of the critical care transfers from Darwin to interstate centres were performed by civilian retrieval services. In conjunction with Qantas, many ambulant patients were also evacuated directly from Denpasar by civilian aeromedical teams. Several issues became apparent in the coordination of the civilian aeromedical evacuation from Darwin. These were: Lack of knowledge by federal emergency coordinators of available civilian aeromedical resources, which led to delay in activation; Lack of a national coordination system for medical retrieval, so transport from Darwin was organised by personal contacts and offers of assistance rather than a systematic approach, resulting in ad hoc utilisation of services; Insufficient coordination between personnel organising the transports and the receiving burns centres, resulting in unequal distribution of patients to interstate burns units; Substantial delays while funding was found to charter jets for transporting critical patients. In Australia, most disaster planning is done at state level, and essentially all disaster response resources, with the exception of the ADF, are held at state level. Although the ADF has the capability to carry large numbers of patients, their aeromedical evacuation teams have little peacetime exposure to critical care transport and their equipment is limited. Some incidents require specialised medical or rescue responses that exist only in the civilian setting.7 A mechanism is required for rapidly accessing these specialist state-based resources for incidents that overwhelm the resources of an individual state or occur outside Australia. Medical retrieval resources are another highly specialised resource held only at state level. However, most state services do not have experience in the coordination and logistics required (or even the capability) for very long distance transport, so devolving overall responsibility to the states in situations like the Bali bombing is not practicable. Therefore, a national coordination system that is aware of individual service capabilities and that can tailor the response accordingly is required. A possible model for a national retrieval networkIn Australia, a national network coordinates specialist burns services in the event of a major burns incident. The burns network currently functions by direct liaison between the states’ burns unit directors as required. The burns network can identify beds for burns victims in other states when the resources of one state are overwhelmed. However, there is no system for coordinating the transport of patients. A network of civilian retrieval providers with long distance capability, functioning in a similar manner to the burns network, could be established to coordinate responses to events such as the Bali bombing, which require distribution of casualties across states outside of usual referral patterns. Such a national medical retrieval network would require no ongoing funding, as it is essentially an informal network of service directors. However, funding sources for aircraft charter and a streamlined mechanism for contacting federal and state officials are necessary if the network is to be able to mount rapid, coordinated responses. Advantages of a national retrieval network include: Coordination of patient transfers, in conjunction with other specialist services such as the burns network; Systematic activation of civilian retrieval services, taking into account individual service capabilities; A single access point for retrieval network activation by federal or state agencies, and a dedicated medical officer for liaison with the ADF, if required; and Single-phone-call access to specialist medical retrieval advice, activation of appropriate specialist medical personnel, mobilisation of medical equipment and transport resources, and overall coordination of the medical response by personnel with many years of experience in long distance (interstate and international) critical care transport. In events outside Australia where security is not in doubt, a civilian reconnaissance team sent by commercial or charter jet may be of considerable value while the slower, larger ADF aircraft are in transit. Civilian jet aircraft that can transport teams of up to 10 medical personnel plus equipment could be rapidly mobilised to perform initial intelligence gathering, and resuscitate and prepare patients for transport before arrival of military transport aircraft. A number of organisations have expressed interest in developing a national retrieval network, including the Australasian College for Emergency Medicine and the two largest state-based retrieval services with international capability. Implementation of such a network should result in more timely and better coordinated utilisation of civilian retrieval resources in any future mass casualty incident. 1: Summary of patient injuries on the first Qantas flight from Denpasar Triage category (number of patients) Injury types Treatments required Red (8) Burns ranging from 20% to 30% (including facial), dehydration, lacerations, fractures, shrapnel injuries, blast injury to eye. Intravenous fluid, analgesia, dressings, and antiemetics. Yellow (6) Depressed skull fracture, limb fractures, lacerations, chest and neck pain, abdominal pain, anxiety, blast injury to ear and eyes. Bandaging, sedation, and observation. Green (5) Lacerations and emotional disturbance. Assessment and support. 2: Critical care aeromedical evacuations from Darwin Departure* Aircraft Team Patients Patients’ homes Destination 08:50 Mon Lear 35 (2 stretchers) Royal Adelaide Hospital 2 Melbourne; Melbourne Adelaide 14:00 Mon Lear 36 (1 stretcher) Royal Adelaide Hospital 1 Sydney Adelaide 17:30 Mon Super Kingair (2 stretchers) Royal Flying Doctor Service (QLD) 2 Sydney; New Zealand Brisbane 18:00 Mon Super Kingair (2 stretchers) Royal Flying Doctor Service (QLD) 2 Brisbane; Sydney Brisbane 19:00 Mon Lear 35 (2 stretchers) Royal Adelaide Hospital 2 Darwin; Perth Adelaide 21:00 Mon Westwind (2 stretchers) CareFlight (NSW) 2 Melbourne; Brisbane Sydney 23:30 Mon Lear 36 (1 stretcher) Royal Adelaide Hospital 1 Canada Melbourne 01:00 Tues Hercules C-130 Royal Australian Air Force 2 Perth; Perth Perth 05:00 Tues Citation Medical Emergency Adult Retrieval Service (VIC) 1 Brisbane Melbourne 03:00 Tues Hercules C-130 Royal Australian Air Force/Royal Adelaide Hospital 1 Melbourne Melbourne 17:50 Fri Lear 35 (1 stretcher) Royal Adelaide Hospital 1 South Africa Adelaide * Departure times are Australian Central Standard Time (UTC +09:30). 3: A team from CareFlight Sydney preparing a patient for transport to Sydney

Minh D Tran MB BS, BSc(Med) · Alan A Garner MB BS, FACEM, MSc · Colin Xavier MB BS, FACEM · Ion Morrison DipPH, FAFPHM, FRAeS · Peter H Sharley FJCICM, FANZCA, FFICANZCA · William M Griggs FANZCA, FJCICM, DipAvMed

After the Bali bombing on 12 October 2002, injured Australians were evacuated to Darwin. The first patients arrived at the Royal Darwin Hospital (RDH) 26 hours after the blasts. RDH assessed and resuscitated 61 patients (including 20 intensive care patients, with 15 requiring ventilation, 19 surgery and more than 20 escharotomies). RDH evacuated 48 patients to burns centres around Australia within 36 hours of the first patient arrivals at the hospital and 62 hours after the bomb blasts. The response was successful, but improvements are needed in coordination between the different groups involved in such operations. At 07:45 CST on Sunday, 13 October 2002, a patient was seen in the emergency department (ED) of RDH with minor lacerations and a remarkable story. The patient described being in a nightclub in Kuta Beach, Bali, about 10 metres from the primary blast. He escaped by climbing through a collapsed roof, past dismembered bodies, and then ran to the airport, where he caught the next flight out of Bali. External Disaster Plan activationAt 09:30, the Director of Emergency Medicine notified the General Manager and Medical Superintendent of RDH, and Level 1 of the External Disaster Plan was activated. Over the next few hours, the only news came from television reports and Australian doctors in Bali using mobile telephones to ask for assistance. On the Sunday morning, like many organisations in Australia, RDH offered to send retrieval teams to Bali. The main impediments to this were that aviation companies were not willing to fly into an uninsured environment and ground clearance for landing was difficult to obtain — the first RAAF Hercules C-130 aircraft only obtained landing clearance as it approached Denpasar. During the morning, key clinicians and administrators considered the capacity of RDH to respond. This information was conveyed to the Northern Territory’s Chief Minister, who contacted senior officers of the Commonwealth Department of Foreign Affairs and Trade. The decision was made to use Darwin as the first Australian retrieval port for seriously injured victims. Darwin is geographically uniquely placed to act as a forward general hospital for disasters in our region. Located 1765 km from Denpasar, a little more than two hours by air, Royal Darwin Hospital (RDH) was the closest tertiary referral facility in Australia for victims of the Bali bombing. RDH is 10 minutes by ambulance from the international airport. In sustained air evacuations, pilot hours are often a rate-limiting step; small increases in cycle time (length of flight and turnaround time) can have major effects on pilot availability. At 14:00, the first RDH control-room meeting occurred, and Level 2 of the External Disaster Plan was initiated (ie, fully prepare RDH to receive the injured). Control-room meetings occurred every few hours over the next 24 hours. At this stage, little was known; we planned for between 50 and 200 patients, with 50% being “walking wounded”. At 15:00, RDH was informed that it would be the sole initial receiving hospital for the Bali victims. We did not receive information on patient numbers or injury severity until the first wave of patients arrived. Preparing to receive bomb victimsBetween 14:00 and 18:00, 24 RDH inpatients were transferred to the collocated Darwin Private Hospital. Specialist-led discharge rounds cleared a further 20 beds. This enabled the establishment of a 48-bed receiving ward. All outpatient clinics and operating lists for the following five days were cancelled, with affected patients contacted. The local media broadcast announcements informing the community of the events about to unfold and asking potential patients with non-urgent conditions to make alternative arrangements. Despite this, there was no decrease in the number of usual attendances, probably because RDH has the only ED in the region. Additional linen, stores and pharmacy supplies were distributed to the ED, intensive care unit (ICU), theatres, and receiving ward. Additional equipment was borrowed from Darwin Private Hospital. Nearly 600 RDH staff were recalled by telephone cascades and deployed over the next few hours. The ED mobilised its disaster stores and augmented supplies of consumables (particularly cling wrap for temporary burns dressings, morphine, ketamine, rocuronium, tetanus toxoid, antibiotics and O Rh-negative blood). A fibreoptic intubating scope was added to the usual “difficult airway” boxes. All suxamethonium was removed from the ED to prevent a depolarising relaxant being used in error. Before the arrival of the first patients, group tutorials were held covering burns dressings, escharotomies, and fluid and airway management. The lines of command were made explicit. The ICU occupancy could, fortuitously, be reduced to one patient before the Bali patients’ arrival. The ICU is designed for eight patients, but can accommodate 12 ventilated patients. Four additional beds were created in the adjacent coronary care unit and another four in Darwin Private Hospital. Six ICU bays were set up as emergency primary receiving resuscitation bays in the event of ED saturation. All hospital albumin supplies were sent to the ICU and more were ordered from the Red Cross Blood Bank. Four operating theatres were made available for bomb victims, with a fifth theatre kept for other emergencies. The rostered staff of the day prepared three of the theatres with invasive monitoring, fluid-warming devices and forced-air warmers. Equipment limitations meant the fourth theatre was set up for less critically ill patients. At 15:00, the first of five Hercules C-130 aircraft from RAAF Base Richmond, near Sydney, landed in Darwin before proceeding to Bali. Two specialists (an anaesthetist and a general surgeon) from RDH joined the flight with surgical supplies. The familiarity of the Darwin-based medical Army Reservists to both civilian and military sectors facilitated the rapid acquisition of additional supplies and equipment in Darwin. The Australian Defence Force (ADF) team’s involvement has been previously described.1 At 18:00, RDH was ready to receive patients. There followed an 8-hour wait until the first arrivals. Patients arrive at Darwin airportAt Darwin airport, the Site Medical Commander (the Director of Anaesthesia) headed a hospital team of two anaesthetists with ICU experience, two ICU nurses and two aeromedical retrieval doctors. This team met each of the Hercules C-130 aircraft (which were carrying between 11 and 22 patients), and the Site Medical Commander received handover from the aircraft’s ADF medical staff. This too was facilitated by many ADF staff being known to RDH staff (reservists working in RDH or living locally). The Site Medical Commander was in mobile phone contact with the ED Director for a brief handover of the critically ill patients. He also liaised with the ambulance controller to maintain ambulance departure rates so that one patient arrived at the ED every 3–5 minutes. Just two patients were directly transferred interstate from the airport by interstate retrieval teams. Most patients required stabilisation before further transport could be considered. The RDH staff accompanied the most critically ill patients to RDH, continuing resuscitation in transit to the ED, where they led ongoing resuscitation efforts and followed through to ICU or operating theatres. This streamlined care by obviating the need for multiple handovers. Patients arrive at RDHOn arrival at the ED, each patient was triaged by the ED Director with the assistance of a senior ED nurse. Four patients were triaged directly to ICU when ED capacity (18 simultaneous resuscitations) was approached. No patients were triaged directly to the operating theatre or to palliative care only. Understandably, minimal documentation arrived with the patients. Some patients remained unidentified for many hours. Patient tracking (with a team of three ED receptionists) was initiated at triage. Each patient was tagged with a preset Hospital Record Number, and a pre-made disaster documentation pack was attached to the patient’s bed. The disaster pack contained pre-printed labels, trauma sheets, burn charts, medical record continuation sheets, blood and radiology forms and a labelled bag for clothing and belongings. A fourth member of the patient tracking team consolidated the computer record for each patient before the patient left the ED. The ED was divided into four clinical areas and six teams (Box). The clinical areas comprised resuscitation (6 beds), majors (6 beds), minors (6–10 beds in an adjacent outpatient area) and a fourth area for “non-Bali” patients. An ED consultant led each of the disaster receiving areas. It rapidly became apparent that there were no “walking wounded” patients. One man with 50% burns was triaged to the minors area when there were 12 more seriously injured patients already occupying the resuscitation and majors beds. ED junior medical staffing was augmented with residents and registrars from non-ED areas to create 18 receiving teams. Medical students were used to provide a delivery service between areas, assist with investigations and look up results, and to help compile complete and accurate medical records for each patient. Important assistance was also provided by a floating general surgeon, orthopaedic surgeon and radiologist, facilitating rapid decision making. After being assessed and resuscitated in the ED, patients were reassessed by surgical teams on entry to the receiving ward. It quickly became apparent that these teams were becoming overwhelmed, and a blanket referral was made to the hospital’s physicians for assistance. Four physician-led “metabolic” teams were rotated through the receiving ward, re-assessing, continuing fluid resuscitation and detecting some missed injuries.2 Despite ongoing resuscitation, two patients initially sent to the receiving ward were promptly identified by the medical teams as requiring ICU transfer. Twenty ICU admissions resulted from the disaster. Offers of assistance came from interstate doctors in Darwin, but it was difficult to find tasks for them, and at times crowding in the ICU from staff without tasks made management more difficult. In contrast, late on the evening of 13 October a requested Royal Adelaide Hospital specialist burns team arrived. They immediately fitted into our teams and performed surgical burns care unstintingly for the next 24 hours, before returning to Adelaide to continue work on Bali victims. Patterns of injury and resuscitative proceduresTwenty-eight of the 61 patients seen in RDH had major trauma (Injury Severity Scores of 16 or greater). The full range of blast injury sequelae were seen, including severe burns, missile injuries from shrapnel, limb disruption and pressure-wave injury to ears, lung and bowel. Several patients had undergone surgery in Bali, including escharotomy, amputation, laparotomy and suturing of blast wounds (which subsequently were laid open owing to overt infection). Only patients with injuries deemed of immediate surgical importance underwent surgery in Darwin. Fifty-five escharotomies were performed (mostly in the ED and ICU), and, in the operating theatres, 43 other surgical procedures (on 20 patients) were performed, using 50 hours of theatre time. Three patients arrived intubated from Bali, a further 12 patients were intubated in RDH: two in the ED, four in the operating theatre and six in the ICU. Most were difficult intubations because of facial and airway burns and oedema. Suboptimal fluid resuscitation before arrival may have been fortuitous in maintaining patent airways, as increasing airway oedema with fluid resuscitation in RDH necessitated expert airway skills and ventilatory support that may not have been available in Bali. Despite fluid resuscitation, three patients with blast injuries required haemofiltration because of severe acidosis, rhabdomyolysis and rising serum potassium levels. Evacuation to specialist burns unitsOnce the extent of the disaster was known, it was evident that patients would need to be evacuated from Darwin to specialist burns units throughout the country. No single hospital in Australia has the capacity to effectively manage 61 patients with severe burn and blast injuries. A teleconference between RDH and representatives from the Commonwealth and state health departments was held on Monday, 14 October, at 14:00 to coordinate the mobilisation of resources. The RAAF would evacuate the ward patients to their home states in Hercules C-130 aircraft. Critical care trained retrieval teams from Queensland, New South Wales, Victoria, South Australia and Darwin evacuated ICU patients to interstate burns units. Within 24 hours of the initial teleconference, 14 ICU patients were evacuated. Three additional patients were evacuated to interstate burns units over the next few days. The Darwin ambulance service was pivotal in the ICU evacuations. The ward patients were evacuated by four RAAF flights of about 10 patients each, with 2 hours to transport and load each flight. The flights went to Perth, Brisbane, Sydney, and Melbourne (via Adelaide). The first C-130 flight, at 24:00 on Monday, 14 October, also carried two ICU ventilated patients. In total, 48 patients were evacuated from RDH. The evacuation was successful in achieving the aim of sending patients safely to definitive burns care, in most cases in patients’ home states. CommunicationOf critical importance in all phases of the response, from Level 1 (Alert) to Level 4 (Stand Down), was communication. While our emergency procedure manual clearly outlined communication protocols, as an offshore external disaster Bali presented a number of unique challenges. From the earliest phases, communication was established with the Northern Territory External Disaster Committee and with national disaster coordinating bodies. Within the Northern Territory, although most of the activity occurred at the hospital and the airport, a central disaster command centre was established at the police headquarters, with the task of assisting in the coordination of the police, fire and emergency response, and local government and non-government agencies. From a federal perspective, communications needed to be maintained with various organisations, including the Australian Defence Force, the Commonwealth Department of Health and Ageing, the Australian Customs Service and the Australian Federal Police. Initial information about the extent of the disaster was confused and inaccurate. The most accurate reports were those conveyed directly to the hospital from Bali. RDH army reservist medical officers were deployed to the disaster site on the first flights, resulting in improved information flow. Direct communication within the hospital quickly exposed the pitfalls of electronic mail (too busy to check), mobile telephones (lack of reception) and land lines (not mobile), and revealed the future potential benefit of “hands free mobile communications devices” between key individuals. Directors of departments met in the control room every few hours, and this enabled effective anticipation, flexibility of planning, dissemination of information, and resource management. Given the unique nature of the event, the hospital became a centre of national and international media convergence. The response involved round-the-clock media management, additional security, cleaning, catering, administrative and engineering services to deal with a range of contingencies. Relatives and friends of those in Bali required a constant, up-to-the-minute information service. An RDH hotline was manned by finance staff and administrative officers. Psychological aftermathOverview debriefing sessions were centrally organised for all staff, starting on Tuesday, 15 October. These were run initially by lead clinicians, and continued by the hospital counselling service, until all involved staff within and outside the hospital had been given an opportunity to attend. In debriefing staff, a cognitive approach was taken to dealing with acute stress disorder3 after the event, in the realisation that we were unlikely to be able to affect long term rates of post-traumatic stress disorder.4 Sessions aimed to put team efforts in perspective, so that people were able to see their role in the overall disaster management process. Focus was placed on coping with normal feelings of sadness and loss. Small group sessions were also held in all workplaces to give work colleagues the opportunity to share their feelings and coping strategies. It was also important for staff to get progress information on patients for whom they had cared. Formal and informal debriefing continued for four weeks, during which time a sense of camaraderie and achievement developed. This was helped by messages of appreciation from other hospitals, professional bodies, people from all over Australia and the victims and their families. Patient outcomesAt the time of writing, it is our understanding that, of the 61 patients retrieved to RDH, one died in RDH, three died after interstate transfer, and one remains hospitalised. The other 57 patients have been discharged home. It is our opinion that the survival rate is higher than expected given the nature of the injuries, the environment of the disaster and the time taken to delivery of definitive care. The successful outcome is attributable to teamwork at every link in the chain of care from Bali to the eventual discharge of patients. One of the defining experiences of those 62 hours was the level of teamwork between organisations, departments, professional groups and individuals. It is a rare privilege to work in an environment completely stripped of hidden agendas and professional boundaries. ConclusionsEffective federal command, control and communication for multijurisdictional disasters is crucial, and worked reasonably well in the Bali evacuation. However, these experiences must be built upon. An Australia-wide disaster plan should be reworked in the light of the Bali experience, especially for remote and offshore areas. In particular, the military–civilian interface needs development; there needs to be central coordination of non-government retrieval teams (especially in the initial response); and lines and methods of communication need reinforcement. The concept of a “forward general hospital” to resuscitate injured evacuees is an established military model and worked well in this operation. The RAAF is the only organisation in Australia with the capability to evacuate large numbers of injured by air, and should be included in disaster planning for remote Australia. If a model of a “forward general hospital” is accepted for remote areas, then these hospitals should be designated and funded for the task. If there is no available forward general hospital, the Australian Defence Force has the capability to airlift a temporary tent hospital close to the disaster site, and this should be included in the disaster planning for those areas. In disaster medicine at all levels, from federal government to individual emergency departments, detailed plans are in place for most contingencies, but these are rarely tested beyond tabletop exercises. In our experience, tabletop exercises are of limited value, as they only identify theoretical problems in communication, equipment, personnel availability and timing — real problems can remain hidden. Disaster exercises with mobilisation of assets and “real time” communication should be set as the benchmark for testing disaster plans. Such exercises, especially at the complex interorganisational interfaces, require funding. In some ways, the Australian Bali response was straightforward — delayed patient arrival, single retrieval agency, single receiving hospital. If a bomb exploded in a crowded Australian nightclub, the required immediate response would be infinitely more complex. RDH has acted as the advanced receiving hospital in Australia’s largest-ever offshore disaster requiring urgent evacuation. It recognised its limitations and acknowledged the need for assistance immediately, safely disseminating a large number of patients to home bases after clinical stabilisation. Panoramic view of the emergency department (ED), and schematic of the ED command structure

Didier J Palmer FRCS, FFAEM, FACEM · Dianne Stephens FANZCA, FJFICM · Dale A Fisher FRACP · Brian Spain MRCA, FANZCA · David J Read FRACS · Len Notaras LLB, BMed, MHA

After the Bali bombing on 12 October 2002, once the survivors had been treated or evacuated, many dead, severely burned and fragmented bodies were left. Formal identification was required before any remains could be released to grieving families. Australia sent a team to assist the Indonesians in this daunting and disturbing task. The “disaster victim identification” process eventually confirmed 202 people as dead, including 88 Australians. Personal and professional relationships between the Indonesians and our team were important factors in our acceptance into the Indonesian emergency response. At 06:00, Sunday, 13 October, Professor John Hilton (Director of the Institute of Forensic Medicine, Sydney; Associate Professor of Pathology, University of Sydney; and Group Captain (ret.) in the RAAF Specialist Reserve) heard on the radio news that there had been an explosion in Bali, with an unknown number killed or injured, including Australians. John: Thought 1: Must have been an LPG storage tank in a hotel or restaurant or nightclub that blew. Thought 2: What’s the actual size of the problem? I had vivid memories of wild exaggerations of fatalities in East Timor in the aftermath of the independence referendum. Thought 3: Will the Indonesians need some help with the DVI [disaster victim identification], the forensic pathology and odontology? Thought 4: Ring the State DVI Commander [Detective Chief Inspector Mark Edwards] and ring Griffo [Chris Griffiths, Staff Specialist, Westmead Centre for Oral Health; Adjunct Associate Professor, University of Sydney; and Group Captain in the RAAF Specialist Reserve]. Paddy’s bar During the day, a picture of bombings, rather than a gas explosion, emerged. John Hilton and Chris Griffiths (Staff Specialist, Westmead Centre for Oral Health; Adjunct Associate Professor, University of Sydney; and Group Captain in the RAAF Specialist Reserve) worked with Superintendent Andy Telfer of the South Australian police, head of Australia’s delegation to Interpol, and, by proxy, with the Department of Foreign Affairs and Trade and the Australian Federal Police (AFP), to formulate a response plan and compile and assemble an equipment list. The AFP was appointed the lead agency in the DVI response. However, DVI is a new area for the AFP; the expertise lies with the states. On Monday, 14 October, John Hilton and Chris Griffiths flew to Bali, arriving late in the evening. Meeting the IndonesiansOn Tuesday, 15 October, we were up at 05:00 for a breakfast meeting with the AFP in Denpasar. At 08:00, we headed to the site of the bombing, but were denied access because the previous day the AFP had advised the Indonesian police to seal the crime scene and not let anyone in. We went on to Sanglah Hospital, a pleasant pavilion-style tropical hospital coping valiantly with the victims of the bombs, and met Police Brigadier General Eddy Saparwoko, the Indonesian DVI Commander, and Lieutenant Colonel Peter Sahelangi, an Indonesian police odontologist. We made it clear we were there to offer help and were entirely at their disposal. Saparwoko asked us to assist in managing the identification process according to agreed international standards. Chris: I’d been the Australian delegate to Interpol's DVI Standing Committee for the last eight years and also their Scientific Vice Chairman. Through this, I had a long association with the Indonesian police. In Makassar (in south Sulawesi) in 2002, in conjunction with the Indonesian police, this Standing Committee had organised a South East Asian Meeting that was attended by South East Asian police colleagues and the majority of the regional police chiefs of Indonesia. It was basically because of these associations that Brigadier General Saparwoko asked us both to help him supervise and oversee the identification process. We also met with the volunteers who, under self-selected leadership, had laboured mightily to start the identification and relative support process. Unfortunately, as they had no previous experience or skills in this area, many of their efforts were inappropriate. We dissuaded them from unproductive efforts and encouraged them to follow agreed standard tracks. The disaster victim identification processThe process of DVI comprises three steps: collecting ante- mortem (AM) identifying data, collecting postmortem (PM) data, and reconciling the AM and PM records to make positive identifications. Collecting antemortem dataIn Australia, AM data collection is under the control of police missing persons units. Researchers gather as much information as possible about people believed to be victims. Information gathered includes dental records, history of broken bones or surgery, tattoos and scars — anything that might assist in making a positive identification. Destroyed vehicles Russell Lain (Staff Dentist at the United Dental Hospital of Sydney; Visiting Staff at the Department of Forensic Medicine; and Lieutenant, Royal Australian Naval Reserve) and William Saunderson (Staff Specialist at the United Dental Hospital), both with many years experience in DVI, worked with missing persons police in Parramatta, gathering AM records for dispatch to Canberra and thence to Denpasar. Colleagues in other states similarly divided their duties between retrieval and analysis of the AM data and fieldwork in Indonesia. Russell: The biggest impact for me was having to deal directly with bereaved relatives. We had to quiz them about possible sources of medical and dental records, charts, x-rays and the like. Some of these people had just come back from Bali. They had been trying to ID their kids from Polaroids of the bodies. They were still shellshocked. And we’re on the phone asking them for details about dentists they might have gone to. Nothing can really train you for this, but we just had to get on with it. The families seemed to take some comfort from seeing that professionals were engaged in a proper ID process. The whole week in the Police Centre doing the AM stuff really brought home to me just how vital that side of things is. Within 10 days of the bombing, all the available AM records for NSW had been gathered. Russell Lain then flew to Bali. Collecting postmortem dataGathering PM data involves careful examination of each body, recording details of personal property, scars, tattoos, distinctive anatomical features, and dental features. The slowest part of the process is gathering the dental data, and an important lesson for future mass disasters is that, to avoid delays, more trained forensic dentists than pathologists are needed. Two features that stood out during the PM phase were the scale of the disaster, and the state of the morgue (Box, "Impressions of the morgue at Sanglah Hospital"). Bodybags packed in ice ReconciliationOnce the AM and PM data have been gathered, the records are compared to identify victims. The proposed identifications are reviewed by a Reconciliation Board. The process has an inbuilt scepticism that obliges the presenter to illustrate the concordances between AM and PM records. The greatest difficulties arise in cases of poor AM records or incomplete recovery of remains. For the Bali bombing, the Reconciliation Board consisted of Indonesia’s DVI commander (Brigadier General Saparwoko), a forensic odontologist (Professor Chris Griffiths), and an Indonesian forensic pathologist. When all members of the board were satisfied that an identification was correct, a death certificate was issued and the body released to the family. Chris: I sat on the Reconciliation Board for 21 consecutive days, overseeing the dental evidence. After three weeks of playing devil’s advocate, I was physically and mentally drained. More than 60 per cent of victims of all nationalities were identified using dental evidence within three weeks of the incident. Most of the later identifications were based on DNA evidence. This formal standard identification process is extremely important. Of the 18 victims who had been “identified” visually by families, nine were shown to have been identified incorrectly. If bodies had been released on the basis of these family identifications, we might have had nine families, or even more, whose child or parent was never identified and never able to be returned. Politics and public relationsA mass disaster naturally attracts political and frenzied media interest. A particular concern in the Bali bombing involved early release of the bodies. We needed to explain the importance of the formal DVI process to the families, the media, and the politicians. Coffins From comments he made in a radio interview, it was obvious that Australia’s Prime Minister, John Howard, was being pressured to have the Indonesian authorities release bodies on the basis of visual identification only. Chris Griffiths phoned the Prime Minister and explained the problems of visual identification and expressed to him our confidence in the Indonesian authorities. Chris also explained that, from our initial assessment, DNA techniques would be needed to identify some of the bodies, and the Indonesian government could not pay the costs of DNA matching. The Prime Minister immediately agreed that the Australian government would cover the costs of DNA matching, irrespective of the victims’ nationality. More difficult was explaining the process to the relatives of the victims. We try to involve ourselves only with the postmortem area of identification. Dealing with the families makes working in the mortuary too personal, as we pick up the grief of the families. Chris: In this case, as I walked in the door to address the relatives, Graham Ashton [Australian Federal Police Commander] said, “There is someone in the group that knows you.” Then I saw an old friend from university. I know his children well. He said simply, “James is one of those killed.” I found it very difficult to talk to the relatives after this, but I had to explain to them that releasing bodies that had been tentatively identified by families could jeopardise the identification process for everyone. From my international experience, at least one in three visual identifications turns out to be incorrect. On Thursday, 17 October, Prime Minister Howard, Deputy Prime Minister John Anderson and Opposition Leader Simon Crean, and their advisers, flew into Bali for a memorial service. We showed them the photographs that had been taken by the volunteers helping the families carry out their visual identifications. Later that evening, we attended a briefing with the Prime Minister’s party, where problems were raised and decisions were instantly made. No months of committee paralysis — just “It sounds like a good idea. Do it!” One issue raised at that meeting was the need to involve the state coroners. The state Coroners Acts require that a local state coroner make findings as to identity and cause of death of any body connected with the state when the death is caused by violence. If Australian bodies were released without a coroner’s approval, it might lead to difficulties with probate or insurance. By coincidence, the annual coroners’ conference was being held in Sydney, so John Hilton left Bali that night to address the conference. The coroners decided to send two representatives to Bali the next day. International team relationsOther countries also sent DVI teams to Bali, and there was some difficulty aligning their efforts with the agreed Indonesian–Australian process. One of the problems was that teams from some countries wanted to work independently of the Indonesian–Australian team and only examine non-Caucasian victims. We had to point out that non-Caucasian people were not necessarily nationals from South East Asian countries. The victim lists showed many victims were ethnically of Chinese origin but citizens of Canada, the United Kingdom, the United States or Australia. We also showed them the severe burning of many of the victims, which made it impossible to determine racial groupings. Eventually the various teams agreed to integrate with the international team and to examine each body in order. Time outFatigue is a major issue in this type of work. Team members will always tend to push themselves to the point where they can no longer function efficiently. This is when mistakes are made. It is up to wiser heads to enforce full meal breaks and rest days, even if the team wants to continue working. Occupational health and safety concerns are real, and need genuine commitment by managers. In DVI we talk about the different groups of victims. The first group is the dead and injured; the second group is the families, especially those of the dead. There is a third group of potential victims — the rescuers and DVI workers. Russell: I remember we had just had a visit from the cast of the Indonesian version of Neighbours. They came through the morgue like royalty, checking the scene and shaking hands. I walked away from that and was in the reconciliation room, working with a colleague to match up AM and PM records for ID. We did about five with no joy. Then we realised we were trying to match AM records with other AM records! We had the next day off. On the morning of our day off, the security adviser warned us that we were being targeted. We were not to go out alone; we were not to answer questions from locals about what we were doing or how long we would be there; we had to sign in and sign out; we had to carry an encrypted radio, water, money and passports if we were going any distance; we had to be back by dark, keep alert and “have a good day”. Apart from an uneasy feeling when any van like the one used in the bombing pulled alongside our minibus, we did have a good day. Terraced rice paddies, charming villages, nearly deserted streets decked out with colourful misspelled signs expressing sympathy for the victims of the atrocity; those classic Asian city smells of garlic, sewage, coriander and diesel, and everywhere those delightful smiles, even in the face of a devastated economy. It was a good day. During the weeks in Bali, we stayed at a luxurious hotel, which seemed a bit incongruous in the face of the suffering just outside the gate and the serious job we were doing. However, it is important for the team to have a safe haven to relax in, maybe discuss issues that had come up during the work day, and allow the battered psyche to recharge. Russell: The hotel had a pool the size of the Mediterranean. There’s a few photos — which I hope never surface — of this pale-skinned crew around the island bar with huge drinks with pink parasols. “The gathering of the Beluga whales”, I called it. The AFP paid for two drinks a day. Happy Hour — that’s half price, four drinks — was between five and six every day. Most days we got back to the hotel between five and six! ConclusionWe all learned a lot from that Bali experience, such as the importance of the AM data collection, and a better understanding of DVI fieldwork. It also became clear to us that this was as much an attack on the Balinese as on the tourists. Family member of Indonesian victims praying at the bomb site The relationships cemented during the time in Bali represent the prime benefit of the process. The value of long term associations and friendships with colleagues in Indonesia was borne out during the Bali incident. For us to go to another nation and be accepted into their organisational structure in an emergency situation was vital for the early identification of the victims and their early return to their families. Hospitals, universities and many healthcare professionals in Australia tend to form their associations with European and North American organisations, because of history and the scientific knowledge base. However, if we are going to be good neighbours, we should try to develop stronger ties with our immediate neighbours, on both a personal and a professional level. We may feel that the information flow is somewhat one-sided. But this is what being a good neighbour is all about. We are reminded of Aesop’s fable of the mouse and the lion. Sometime in the future good deeds will be remembered. This is especially so in South East Asia. Impressions of the morgue at Sanglah Hospital Russell: I had been involved in the Thredbo landslip, the Glenbrook train crash and several light plane disasters. But when we walked past the cordon of soldiers and their M-16s at Sanglah Hospital and saw 200-plus body bags and a pile of body part bags laid out on a tiled walkway, the numbers hit home. I was nervous about the smell. I’ve been doing this work for 10 years but I just hate the smell. I knew it would be too hot to wear a proper charcoal face mask, so I was wondering if I’d be sick in front of the Indonesians. Anyway, it was amazing. The morgue just did not smell. Well, not too bad anyway. The volunteers kept up a constant bucket brigade of ice and packed it around the bodies. They were fabulous and always had great smiles. The problem was that the ice melted. When the volunteers lifted a body bag onto a trolley for a PM or x-rays, brown juice just poured out of the bags. They mopped it away, but five minutes later there would be another brown pool on the floor. One of the Japanese odontologists saw me staring at this on my first day in the morgue. “Human soup”, he beamed at me cheerfully. That was one of the worst bits. That and walking in among scores of body bags — they were packed pretty close — looking for a certain number bag for a re-examination, and trying very hard not to tread on the bodies.

Russell Lain BDS, DipForOdont · Chris Griffiths BDS, LDS, DPH · John M N Hilton RFD, MB ChB, FRCPA

There is little disagreement about the directions public health reform should take — greater emphasis on primary and preventive care, workforce reform, community participation, improved governance and better application of information technology. It is clear that there are gaps and duplication in clinical services that reflect outdated population patterns and jealously guarded clinical territories. There is concern about the health disadvantage of certain groups, and particularly Aboriginal and Torres Strait Islander people. In quality of life measured by life expectancy, Australia ranks number two in the world, but in healthcare equality we rank number 17.1 If all Australians had the same health experience as Aborigines, we would rank number 140 in the world, alongside Bangladesh. These issues are common to many advanced healthcare systems. This is confirmed by almost any healthcare enquiry or commission. One doesn’t have to be a rocket scientist to know where we need to head. But there is considerable disappointment and disillusionment about the ability of the leaders of our health systems to lead and manage the change. And the public is right about the failure of health leadership — political, clinical and managerial. In the two inquiries I headed in New South Wales2 and South Australia,3 the cynicism I encountered was abundant and depressing. I was continually told that “your inquiry may be well and good, but nothing will really happen”. I understand their cynicism. It is part of a larger issue of alienation, which the community feels towards all our major institutions — parliament, political parties, the media, trade unions, companies, and churches.4 We so often feel that they are not honest and open with us, and that they try to manage and manipulate information to protect their own interests. Major institutions have lost touch with their natural constituencies. It is true in healthcare. I would like to identify briefly some of the major underlying problems and then suggest some possible ways forward. My comments are very much influenced by observing, at close hand, the NSW and South Australian health systems and the way they relate and react to Commonwealth health funding. There is clearly a failure of the Commonwealth and states to cooperate in the funding and delivery of healthcare services, with resulting inefficiencies, buck-passing, cost-shifting and poor integration. It was made clear to me in NSW and SA that the public wants change here, but doesn’t see any leadership through the impasse. There is a lack of honesty by governments as to what the healthcare system, with limited funds, can reasonably provide. As a result the public has unrealistic expectations and the health workforce is under great pressure. In this situation, political mischief by Oppositions is easy. Unless governments face this issue of limited funds and rationing, and are honest with the public, they will always be under pressure and in crisis, with numerous bandaids applied, but no system change. The healthcare system is remarkably inward looking. The debate is between insiders. The community is not enfranchised or involved. If I have been able to contribute anything to the health debate, I believe it is because I am an outsider. There is clearly waste in the present system, with a $2.5 billion private health subsidy that produces few obvious health dividends. There is widespread overhospitalisation, overservicing in some areas, duplication of clinical services and large central health bureaucracies. We have a very institutionalised, medicalised and hospital-centric system, rather than a health system. The debate and resources are pre-empted by hospital interests at the expense of, for example, primary care, prevention, clinical support in the home, more appropriate facilities for the aged, and hospital avoidance programs. Hospitals should be the last resort, but, in the current system, they are often the first. There is the problem of the quality of healthcare, and avoidable adverse events as a result of spreading our skilled clinical services too thinly. In attempting to tackle these issues, the plea invariably is “more money please”. More money is clearly necessary in key areas, but more investment in doing the same things the same way will only delay reform. It encourages just the attitude that is at the centre of our problems — that resources are unlimited and that choices do not have to be made. It will be the same old treadmill. Governments and taxpayers rightly insist on value for money. Reform will not be successful unless we can persuade treasuries that the money will be better spent in the future. In achieving that, I believe some or all of the following elements need to be in place. A Commonwealth/state health commission should be established in any state that agrees to cooperate with the federal government in the joint funding and operations of public healthcare services in that state. Which state will break the impasse and be the first to put its hand up? Will the Commonwealth respond? We need to move beyond Commonwealth/state pilots and demonstration projects to real system change. I am sure that a joint service would deliver better quality and efficiency of care, even if no additional funds were provided. So let us put that joint Commonwealth/state health commission on the agenda, put the case as compellingly as we can, and hopefully within 3 to 5 years we would have started to break the wasteful impasse and buck-passing of the present divided jurisdictional system. The roles of ministers, health executives, boards and health institutions, particularly in the states and territories, must be clearly defined and accountabilities established. The micromanagement of healthcare systems by ministers and their private offices must be stopped. I have heard and seen at first hand endless cases of private ministerial staff members who suppose that, as the minister’s alter egos, they can hector quite senior clinical and non-clinical staff. Some members of ministerial staff even think it is appropriate to try to micromanage external and independent committees of review. This is not a new problem, nor is it restricted to one government. It is a very serious problem. Certainly, ministers and their offices need to manage short-term crises and they need to get on top of some of the detail, and there is a lot of detail in healthcare, but so often they allow themselves to be submerged by the detail, lose their way and allow the nightly TV news to set the agenda. So, ministers spend disproportionate amounts of time putting out brush fires. Media management and micromanagement by ministers and their offices go hand in glove. This preoccupation with daily crises and micromanagement has many unfortunate consequences — long-term issues, such as the reform agenda we are discussing at this summit, are put on the back-burner. Senior executive officers are confused and reluctant to make decisions. They become gun-shy. They manage upwards to the minister. The minister becomes the client, and not the public. Disproportionate resources and energy are spent serving the minister, and particularly his or her staff. The central department also becomes too close to the political agenda of the minister, with the emphasis on news management. In my experience, private staff of ministers are petrified at the prospect of robust discussion and debate. This issue must be addressed, or confusion and frustration at senior levels will continue to paralyse the system. Only ministers can lead this change and forgo their micromanagement. It is not only in the interests of a well functioning system for them to do this, but it would seem clearly in their own interests to break out of the daily political cycle of calls for more beds and complaints about ambulance bypasses. The healthcare system would greatly benefit if they would use their political credit and influence to win the debate and change the system — to achieve, for example, better primary care, improved mental healthcare and putting us on track to remedying the most disastrous problem of all, poor Aboriginal health. In speaking of micromanagement, I know I am treading on toes, but if I could paraphrase the words of Confucius when asked “how to serve the minister”, the sage replied “tell him the truth, even if it offends him”. Not only must there be clearer definition of roles, and clear accountabilities, there must also be close linkages between corporate, clinical and community governance. Each role must be clearly defined within an overarching governance structure. Clinical governance in the end must be subject to corporate governance. Managers must recognise the professional responsibility and skills of clinicians. Clinicians must understand the financial and political constraints under which the system operates. It is they who admit patients to hospitals — not patients themselves or even hospital managers. Nothing is ideal, but improvement is possible. Great care is also necessary in choosing boards of governance, for getting the governance structure right will not be sufficient if ministers appoint political or personal extensions of themselves. Similarly, board members must carefully and determinedly assert their duties to ensure good governance, and not knuckle under to short-term pressures. Governance boards are not the same as advisory committees. They must be structured and appointed with full regard to the overarching responsibilities which governance boards have — financial, ethical and legal probity, adherence to occupational health and safety standards, high standards of professional conduct and competence and efficiency. The health agenda must be changed and the community is the key to doing that. I believe that in SA, we have recently made significant progress in presenting a compelling case to the public for change — the main change being a public understanding that we can’t have everything in healthcare. However, the status of the new agenda may be precarious, and could easily revert to the daily political cycle of media headlines about hospital beds and new high-tech equipment. There must be major and successful communication campaigns to establish what are the clear priorities in healthcare spending. Expenditure on healthcare in Australia has increased from about 6% to 9% of GDP (gross domestic product) over the last 40 years. While healthcare demands are almost unlimited, resources are finite. The health budgets of Commonwealth and state governments are clearly not sustainable into the future. I have seen numerous surveys of community priorities in health. They all tell very largely the same story. Whilst the community appreciates the important role of hospitals, they see mental health as today’s top priority, followed by the health of children (particularly children subject to violence), and Aboriginal health. The community speaks very clearly and consistently on these issues, but they do not shape the priorities in spending. Insiders make the decisions. Ministers give lip service to community participation, but many quite seriously believe that they represent the community, so do not see the need for another level of community participation. Unless the Commonwealth and state governments involve the community in setting priorities in health spending, we will not make real progress in systemic reform. We called our South Australian report “Better choices, better health”.3 Choices cannot be avoided. Unless the community is locked in through appropriate structures and processes, health reform will not happen. The public must be connected. Health leaders must acquire and demonstrate proven capabilities in managing change in large organisations. For large-scale change is necessary, and, if I was a minister, I wouldn’t be confident that I had the senior executives who were capable of leading the process. In my experience, the public sector has superior analytical and policy development skills compared with the private sector. But there is a big difference when it comes to being prepared to take risks. Change management is now a significant feature of leadership in major companies in Australia and around the world. It is desperately needed in healthcare systems. While change in healthcare systems must be driven from within, it requires major help from outside experts. The healthcare workforce is composed largely of people of great professional commitment and skill, but they know little else but health. So change is hard to visualise if healthcare is the sum total of one’s work life. Nowhere is the healthcare system in greater need of external expertise than in human resources and industrial relations. These are essential if we are to see a restructuring and rejuvenation of the healthcare workforce, which is, frankly, more appropriate to the needs of the 19th than the 21st century. Training and work are in separate compartments, and work demarcations abound. Restrictive work practices and denial of career prospects, large central offices and shortages in critical areas are rife. There is little linkage between workforce plans (if they exist at all) and budgets, infrastructure planning and delivery of services. The labour market is supply-driven, with little effective linkage between the supply through training and educational institutions and the demands of a changing healthcare system. We are rightly proud in Australia of the workforce renewal that has helped transform the Australian economy. But that workforce renewal has not really touched the professions, and particularly the healthcare sector, where jobs need substantial redesigning and work processes must be significantly re-engineered. Over a period, this could deliver major productivity gains and enhanced job satisfaction, particularly for nurses. New people with resolution, new ideas and new attitudes are essential if workforce renewal is to occur. The solutions to many “health” problems will not be found only within a highly medicalised healthcare system. The greatest cause of poor health is poverty. This is abundantly clear with Aboriginal people. Their poverty and associated bad health are compounded by a lack of hope. I recall in SA an Aboriginal elder telling me that young Aboriginal people say to her “with our grim prospects, what is the point of being healthy”. So a response must be holistic. It requires whole-of-government action, with targets set across a range of portfolios — employment, education, water supply, police and health. And this can only be driven by the Cabinet. Interdepartmental committees will not do the job. Aboriginal health is a national emergency that requires ministerial leadership by every Cabinet minister in Australia, not just health ministers. Because the health system is so inward-looking, an independent and external monitoring body to report publicly on implementation of a change program is essential. Change will be hard, and every day there will be those with vested interests who will want to beat back the change. Not surprisingly, the leaders within the system are likely to lose heart. That is why an independent and strong external group is essential in checking progress and helping to chart the way forward. In this work, that monitoring body needs to focus on a few simple and clear measures of progress. Healthcare produces reams of reports and statistics, but these are not used to measure and drive reform. The Canadians have something to teach us, as in so many healthcare areas, about what are the really important measures of success in health systems.5 Finally, I guess all this comes down to leadership — political, clinical and managerial. My recent experience in SA is that the public wants to be engaged, and responds very positively to a well argued case for change. That case requires leaders prepared to take risks.

John Menadue AO

Acute anterior shoulder dislocations, when managed non-operatively, have traditionally been treated by placing the arm in a sling. There is no formal evidence that this treatment is of benefit. Three recently reported studies, one in cadavers and two in patients, suggest that the detachment of the structures in the front of the shoulder is made worse when the shoulder is placed in internal rotation, as when the arm is in a sling. By contrast, the structures are realigned when the arm is placed in external rotation. Shoulder dislocations, if managed non-operatively, should not be treated by placing arms in a sling. Rather, placing them in a splint or using a pillow so that the the arm is externally rotated should be considered.

George A C Murrell MBBS, DPhil

Croup affects about 2% of preschool-aged children every year. Most children have mild croup and are managed at home, often after review by a general practitioner, who may decide that a single dose of oral corticosteroid is indicated (eg, if a risk factor for hospital admission exists). A minority of children develop moderate or severe croup. They should be reviewed in an emergency department and may need hospital admission. More liberal use of systemic corticosteroids for croup (in both primary care and emergency department settings) has been associated with reduced rates of hospital admission, reduced admissions to the intensive care unit and a reduced need for endotracheal intubation. We discuss the assessment and evidence-based management of a child with mild croup presenting to a GP and a child with moderately severe croup presenting to an emergency department. We present a flow chart summarising an approach to assessing and treating croup in the emergency department.

Dominic A Fitzgerald MB BS, PhD, FRACP · Henry A Kilham MB BS, FRACP

Policymakers need to catch up with the explosion of new tests and therapies The field of endocrinology has expanded dramatically in the past 40 years, both because of increased knowledge about the aetiology, diagnosis and therapy of endocrine disease and because of the increasing number of patients with very common endocrine conditions, particularly type 2 diabetes, osteoporosis and menopausal problems. The development of the radioimmunoassay for hormone measurement in the 1960s was a landmark in endocrinology, as it allowed measurement of hormone concentrations in small blood samples. Since the 1980s, hormone assays have become routine, automated and widespread, with most now readily available to general practice through commercial pathology laboratories. As random measurement of many hormones can give misleading results, it is important that those ordering assays understand their interpretation. In Australia, ageing of the population and lifestyle change have caused an explosion of obesity, type 2 diabetes and osteoporosis. The AusDiab study in 2000 showed that 20% of the Australian population aged over 25 years was obese (body mass index > 30 kg/m2) and, possibly of even greater concern, more than 30% of the population had central obesity, while 7.4% had diabetes, mostly type 2.1 The problem of osteoporosis is also large, caused particularly by population ageing, but possibly also by reduced levels of physical activity, and has a massive impact on the healthcare system and budget. For example, the estimated cost of hip fracture in Australia is $7 billion per annum — $2 billion in direct and $5 billion in indirect costs.2 Endocrinology is at the forefront of evidence-based developments in therapy and primary and secondary prevention. It has been particularly affected by the rapid expansion and improvement of pharmacotherapy and the explosion of information from clinical trials and epidemiological studies on appropriate indications for drug use. In diabetes, new treatments include human insulin analogues with more rapid or more prolonged action. There are newer and better long-acting sulfonylureas, as well as short-acting insulin secretagogues (the glitinides). Alpha-glucosidase inhibitors have been developed to inhibit carbohydrate absorption, and recently the thiazolidinediones (“glitazones” — which combat insulin resistance) have become widely used in most developed countries. Therapy for obesity remains difficult, but better understanding of nutritional approaches, availability of new pharmacological agents (eg, orlistat and sibutramine), and more sophisticated surgical approaches are all important. Our understanding of the molecular mechanisms underlying weight control is improving through cloning of signalling molecules and their receptors. For osteoporosis prevention and treatment, an increasing number of agents have proven efficacy. The selective oestrogen-receptor modulators (eg, raloxifene) have an oestrogen-like effect on bone but not uterus and breast. The newer bisphosphonates are highly effective in preventing decline in, or actually enhancing, bone mineral content by inhibiting bone resorption. Parathyroid hormone is the first drug to increase bone formation and can reduce fracture rates in some patient groups by up to 70%.3 These changes in disease prevalence and in therapy and prevention have raised important issues of health policy. The availability of diagnostic tests for common conditions can be an issue; for example, only four tests of glycosylated haemoglobin (HbA1c) are reimbursable through Medicare per annum for people with diabetes. Of greater concern to physicians, government and the public is the availability and cost of new drugs. For example, thiazolidinediones are not yet available on the Pharmaceutical Benefits Scheme (PBS) over 2 years after the initial application. Nor is growth hormone replacement therapy for adult growth hormone deficiency accepted for PBS subsidy, while patients using corticosteroid therapy are not eligible for reimbursement for effective therapy to prevent bone loss (eg, bisphosphonates), unless they have reached an established diagnosis of osteoporosis with fracture. The availability of such new drugs for the accepted indications will probably pose an increasingly difficult problem as our healthcare system tries to balance restraint on expenditure with improved therapy for the individual. This Practice Essentials series aims to review the most common areas of endocrinological practice, with special emphasis on clinical issues important in general practice. The articles are designed to enable general practitioners, general physicians and physicians in other specialties to remain up to date with the rapidly changing therapies in endocrinology, new diagnostic tests and their interpretations, as well as current issues in health policy and disease prevention.

Jeffrey D Zajac PhD, FRACP · Donald J Chisholm FRACP · Bronwyn Gaut MB BS, DCH, DA

The prevalence of type 2 diabetes in Australia has doubled over the past 20 years; more than 7% of Australian adults now have diabetes. An additional 16% of Australian adults have lesser abnormalities of glucose tolerance. Insulin resistance and increased cardiovascular risk occur in both these groups (the metabolic syndrome). 50% of cases of type 2 diabetes are undiagnosed; screening is indicated in everyone aged over 55 and in younger people with risk factors such as obesity, hypertension, family history or certain ethnic backgrounds. Dietary modification and increased physical activity have been shown to dramatically reduce the incidence of type 2 diabetes in those at high risk. General practitioners should target individuals at high risk, but this needs to be reinforced by community-wide preventive action.

Jonathan E Shaw MD, MRCP · Donald J Chisholm FRACP, AO

Charles P Denaro,* Thomas M Ferrier† * Director of Internal Medicine and Associate Professor, † Physician, Royal Brisbane Hospital, 9th Floor, Ned Hanlon Bldg, Butterfield Rd, Herston, QLD 4029. c.denaroATmedicine.uq.edu.au To the Editor: We comment on the report by Duffy and colleagues of a study of evidence-based care and outcomes of acute stroke.1 The Royal Brisbane Hospital contributed 300 patients to this study between September 1999 and May 2001. As our hospital’s geographically separate stroke unit did not open until February 2001, it is likely that most, and perhaps all, of these patients were cared for in the Department of Internal Medicine, a general medical service. The study compared 1664 patients treated in four types of unit — stroke, neurological, general medical or geriatric units — and found statistical differences between these units. The authors acknowledged that patients in the stroke units were younger than those in other types of unit and also that there “may be differences . . . in complexity and severity of cases that we did not assess . . .”. Our own experience at the Royal Brisbane Hospital may help readers to interpret this study. Our stroke unit has a defined number of beds and resources. While it tries to accommodate as many patients as possible, it often cannot serve all patients with stroke who come to the hospital. Patients of extreme age or with severe illness, caused by either the stroke or comorbidities, or those with adverse cognitive, social or residential status, are often not accepted into the stroke unit and remain in the general medical service. Thus, baseline characteristics differ markedly between patients in our general medical unit and the stroke unit. We are concerned that similar differences exist at the other institutions that provided data for this study. We see little point in publishing 20 separate χ2 tests that contrast differences between the four types of services looking after these patients, unless the baseline characteristics of the patients were very similar and statistically identical. In addition, one could also argue that with this number of statistical tests there would be a good chance of a type 1 error. There is no doubt that stroke units improve outcomes. This makes sense for any acute condition with likely long-term sequelae, as specialty units can provide more resources and a dedicated team of nurses and allied health professionals. However, in our opinion, this study does not provide convincing evidence for the superiority of stroke units over any other type of medical unit, as it is likely that the patients differed significantly between these units. Paddy A Phillips,* Brendan K Duffy,† Miriam E Vedadhaghi,‡ Stephen M Davis,§ Geoffrey A Donnan¶ * Head, † Cardiology Fellow, Department of Medicine, Flinders University of South Australia, Flinders Medical Centre, Bedford Park, SA 5042; ‡ Project Associate, Servier Laboratories, Hawthorn, VIC; § Director of Neurology, Royal Melbourne Hospital, Melbourne, VIC; ¶ Director, National Stroke Research Institute, Melbourne, VIC. paddy.phillipsATflinders.edu.au In reply: We agree with Denaro and Ferrier that there is selection pressure for admission of different types of patients to different units. This was clearly apparent in our study, with stroke units caring for significantly younger patients.1 We discussed in our report that, as this study was not a randomised controlled trial, differences in age and other undocumented factors have potential to bias the results. However, our primary aim was to determine whether current care of patients with stroke in major Australian hospitals accorded with evidence-based strategies. We showed major variations in the use of proven evidence-based strategies in different hospitals and by different specialty units in the real world of Australian healthcare. There were also major and significant variations in outcomes. We believe that all patients with stroke should be cared for in accord with the best evidence available, clinical expertise and their own values2 to produce the best possible outcomes.

Charles P Denaro · Thomas M Ferrier

Brendon J Smith Emergency Physician, Bankstown-Lidcombe Hospital, Locked Mail Bag 1600, Bankstown, NSW 2200. brendon.smithATswsahs.nsw.gov.au To the Editor: The recent article by Szoeke and colleagues on stroke management expressed the hope that thrombolytic therapy will be licensed for use by specialist units in Australia, based on the “proof” of its benefit demonstrated by the National Institute of Neurological Disorders and Stroke (NINDS) trial.1 The NINDS trial was a small, flawed study in which 312 patients received thrombolytic therapy with tissue plasminogen activator (tPA) for stroke.2 Higher scores for stroke severity in the placebo group could themselves explain the improved outcome attributed to thrombolysis. Further clarification has been thwarted by the investigators’ refusal to release the raw data and allow clarification of uncertainty surrounding the results whereby benefit appears confined to those treated at 0–90 minutes after onset, with no benefit in those treated at 90–180 minutes.2 Reports of the introduction of thrombolysis with tPA into clinical practice consistently document substantial protocol violations and worse outcomes than without thrombolysis. The study by Szoeke et al documents mortality attributed to thrombolysis given when protocol criteria were not met, as well as a 23% protocol violation rate in a presumed “best practice” setting. It should be highlighted that their finding in an audit of 30 patients that outcomes were “consistent with reported trial data” means they were also consistent with a worse outcome, although confidence intervals are not presented. Thrombolysis with tPA is not endorsed as a standard of care in stroke by the Canadian Association of Emergency Physicians, the American Academy of Emergency Medicine or the American College of Emergency Physicians; nor do any of these organisations advocate its introduction into practice outside research trials.3,4 In contrast, the American Heart Association upgraded its rating for thrombolysis in stroke from a class IIa to a class I recommendation in its 2000 guidelines without any additional data from randomised trials. Conflicts of interest are substantial and not widely disclosed.2 Genentech, the manufacturer of tissue plasminogen activator, has contributed US$11 million to the American Heart Association and paid for its national headquarters. Six of the nine panellists responsible for the guidelines had financial ties to Genentech, which were not disclosed.5 A dissenting panellist had his name removed from the list of contributors, despite previous assurances that his dissenting position would be published.5 There are not many areas where so much has been made of so little; it falls a long way short of proof. Geoffrey A Donnan,* Stephen M Davis,† Christopher R Levi‡ * Director, National Stroke Research Institute, Melbourne, VIC; † Director of Neurology, Royal Melbourne Hospital, Parkville, VIC 3050; ‡ Neurologist and Conjoint Senior Lecturer, John Hunter Hospital, Newcastle, NSW. stephen.davisATmh.org.au In reply: The comments of Smith may not reflect the consensus of his emergency medicine colleagues. The broad view of the place of tissue plasminogen activator (tPA) is best appreciated from overviews and meta-analysis of all trials of intravenous tPA in acute ischaemic stroke.1-3 Overall, tPA is one of the most powerful biological agents in medicine, with a number needed to treat of about eight to benefit one patient. The integrity of the investigators of the tPA trials is unquestionable. All results were published in journals of the highest repute (including the New England Journal of Medicine, the Lancet and the Journal of the American Medical Association). The National Institute of Neurological Disorders and Stroke (NINDS) trial4 was investigator-driven and funded by the US National Institutes of Health, the highest standard achievable in trial management.5 NINDS receives unrestricted grants from the pharmaceutical industry with appropriate ethical guidelines, as do many societies worldwide. To suggest a linkage is certainly extending conspiracy theory to its limits. Several trial-related issues mentioned by Smith deserve comment. In the NINDS trial, as in many randomised controlled trials, the analysis adjusted for minor baseline imbalances in stroke severity, with no significant impact on outcome. The Melbourne study of Szoeke et al was not a randomised controlled trial, but rather an audit of practice in an expert setting.6 The protocol violations were all relatively minor, and the rate of 23% is comparable with rates in other Phase IV studies.7 Although only a small proportion of stroke patients are eligible for tPA, it is one of the most important advances in stroke medicine. Emergency physicians must play a collaborative role with stroke physicians in delivering this benefit. Kent R Johnson Medical Director, Medical Technology Assessment Group (M-TAG), PO Box 5639, Chatswood West, NSW 2067. kjohnsonATm-tag.net To the Editor: Recent commentators have described the uncertainty surrounding the use of thrombolysis in acute ischaemic stroke.1,2 Recombinant tissue plasminogen activator (tPA) was first approved in 1996, yet its use in stroke still remains low. One explanation is feasibility, as treatment must begin within 3 hours of stroke onset. However, the evidence itself is being questioned.3,4 A recent Cochrane meta-analysis advises caution, noting particularly heterogeneity, and concludes that: “In the light of these considerations, some clinicians may wish to use thrombolytic therapy in highly selected patients; others who are concerned about the definite risks may choose not to use the treatment at all.”4 It is worth revisiting the two studies that supplied the preponderance of data for tPA approval — the two parts of the National Institute of Neurological Disorders and Stroke (NINDS) trial.5 Firstly, the results at face value cannot be considered particularly robust. The first part of the trial (291 patients) showed no difference in the primary endpoint, “early improvement” (resolution or improvement by at least four units on the 24-hour National Institutes of Health [NIH] Stroke Scale). The second part (333 patients) did show a difference in its primary endpoint, a 3-month global statistic6 that simultaneously assessed the Barthel Index, modified Rankin Scale, Glasgow Outcome Scale, and NIH Stroke Scale, with the odds ratio for a favourable outcome with tPA being 1.7 (95% CI, 1.2–2.6; P = 0.008). However, the two parts of this trial also showed substantial drug toxicity (a combined rate of symptomatic intracerebral haemorrhage of 6.4% with tPA versus 0.6% with placebo) with no improvement in mortality (17% with tPA versus 21% with placebo; P = 0.30). Few would describe these results as robust. Secondly, the design strategy added uncertainty to the interpretation. The two parts of the trial were sequential, so that the design of the second could profit from lessons learned from the first: an attractive and common strategy. The studies used identical entry criteria and dosing regimens but different primary endpoints and timepoints. Part 1 “test[ed] whether tPA had clinical activity”, using “early improvement” as the primary endpoint.5 It was then extended for 3 months, and those results were used by the Data Safety Monitoring Committee to design an efficient 3-month endpoint for Part 2. In effect, Part 2 was a test of both tPA therapy and of the new endpoint. This endpoint is then entirely conditional on Part 1; there was no prior trial experience with this endpoint. Consequently, the trial’s success is less generalisable than if a well-established endpoint had been used, and the two parts together carry less evidentiary weight than if they had been fully independent. Paul M Bailey Emergency Physician, Joondalup Health Campus, Shenton Ave, Joondalup, WA 6027. To the Editor: In their retrospective audit of stroke patients presenting to a Victorian hospital, Szoeke and colleagues present a one-sided view of the usefulness of thrombolysis with tissue plasminogen activator (tPA) in acute stroke.1 Proof of the efficacy of tPA in acute ischaemic stroke is far from settled. The National Institute of Neurological Disorders and Stroke (NINDS) trial, in which only 312 patients received thrombolytic therapy, remains the only trial demonstrating benefit from intravenous thrombolysis in a primary outcome measure.2 The study design of the NINDS trial required the enrolment of a disproportionate number of patients with very early stroke (within 0–90 minutes of onset). These patients are rarely encountered in everyday clinical practice. Patients in the 91–180 minute group who received placebo were sicker at baseline than those who received tPA, raising significant doubts as to the efficacy of tPA. After further analysis of the results, the NINDS investigators reported that the greatest positive effect of tPA was seen in the 0–90 minute group.3 The positive effect of tPA in the 91–180 minute group, while not specifically reported, can only have been very small. It is interesting that the median time to treatment in Szoeke et al’s study was 2 h 48 min, implying that 50% of patients were treated in the last 12 minutes of the 3-hour window — when benefits of treatment are at their smallest (should they exist at all), but all the risks of therapy remain. I am also astounded that in the setting of a dedicated stroke unit, with all patients attended to by a team comprising “a stroke neurologist, ‘stroke’ fellow, registrar and nurse”, and a requirement for specific approval for use of tPA to treat stroke in the hospital, that protocol violations occurred in 23% of patients (7/30). That is not the sort of performance that I would want to place in the public domain. Tiny retrospective “trials” are fraught with potential bias, as non-blinded treatments and outcome measures may reflect the enthusiasm of the authors. In addition, significant publication bias may exist — groups with bad results from thrombolysis may not publish. I await the publication of further well designed, randomised, placebo-controlled clinical trials, not linked to the manufacturers of tPA, that demonstrate an improvement in a primary outcome measure in patients treated with tPA before deciding that this treatment may have some use outside clinical trials. I will not hold my breath. Stephen M Davis,* Mark W Parsons,† Kenneth S Butcher,‡ Cassandra E I Szoeke§¶ * Director of Neurology, † Neurologist, ‡ Neurologist, § Registrar, Royal Melbourne Hospital, Parkville, VIC 3050. ¶ On behalf of the other authors.1 stephen.davisATmh.org.au In reply: Johnson correctly points out that the National Institute of Neurological Disorders and Stroke (NINDS) trial had two parts.2 Part 1 was designed to test whether tissue plasminogen activator (tPA) had early clinical activity at 24 hours, and Part 2 was designed to assess whether tPA conferred outcome benefits at 3 months. The results of Part 1 of the trial showed a non-significant improvement in neurological score at 24 hours. However, the finding in Part 2 that there was a significant difference in the primary endpoint (a global test statistic at 90 days) was also true for Part 1 and for a combined analysis of Parts 1 and 2.3 Although there was a substantial increase in symptomatic intracerebral haemorrhage in the thrombolysis group, there was no increase in mortality, and the adverse effects were outweighed by the highly significant benefits at outcome. Johnson’s comment on the choice of endpoints is also of interest. It should be emphasised that the efficacy of tPA in the NINDS trial applied to a range of standard outcome evaluations, including the NIH Stroke Scale, Glasgow Outcome Scale, modified Rankin Scale and Barthel Index, as well as the new global test statistic, which incorporates these scores.2 Many of the issues raised by Bailey have been covered by Donnan et al,4 but some additional comments are warranted. Based on the NINDS trial and meta-analyses of all the intravenous tPA data, this therapy has been licensed for stroke in the United States, Canada, Europe (including the United Kingdom) and many other parts of the world. It is being considered for licensing in Australia. The minor baseline disparities between the tPA and placebo groups have been subject to further rigorous analysis by an independent review committee commissioned by NINDS. This analysis confirmed the statistically significant benefit of tPA within 3 hours.5 The benefits of tPA are indeed time-linked, as shown by further analysis of the NINDS data, but are highly significant right up to the end of the 3-hour window.6 The odds ratio for favourable 3-month outcome with tPA was 2.11 (95% CI, 1.33–3.35) for treatment at 0–90 minutes and 1.69 (95% CI, 1.09–2.62) for treatment at 91–180 minutes. Furthermore, meta-analysis indicates benefit beyond the 3-hour window,7 but there is consensus that further trials are needed to extend the current window, and that tPA should not be used after 3 hours, except in clinical trials. We again emphasise that our audit was not a “trial” and that our protocol violations were generally minor and in line with other expert experience.1 We do not apologise for emphasising the importance of a well-resourced acute stroke team. This is integral to the expert setting required for tPA administration. In 2003, would anyone suggest that patients with acute myocardial infarction should be treated without optimal resources and expert care? Why should acute stroke patients, with high mortality and disability rates, be the poor relations?

Brendon J Smith

James E Fielding,* Heath Kelly† * Epidemiology Registrar, Communicable Disease Control Branch, Department of Human Services, PO Box 6, Rundle Mall, Adelaide, SA 5000; † Head, Epidemiology and Surveillance Division, Victorian Infectious Diseases Reference Laboratory, North Melbourne, VIC. james.fieldingATdhs.sa.gov.au To the Editor: In addition to a complicated ethical approval process, new privacy laws have presented challenges for multicentre research studies.1 In Victoria, an amendment to the Guardianship and Administration Act 1986 came into effect on 1 January 2003. We wish to highlight its unanticipated ramifications. We proposed to conduct a pilot study on the feasibility of ascertaining cases of Murray Valley encephalitis (MVE) in Victorian hospitals. Currently, there is no routine human surveillance for MVE, and we intended to perform diagnostic tests for several encephalitis aetiological agents on routinely collected samples. A study protocol was developed and submitted in November 2002 to five Human Research Ethics Committees (HRECs), one at the Department of Human Services and four at hospitals where the study was to be conducted. The case definition for encephalitis included the criterion that the patient had an “altered conscious state”, and could not therefore give informed consent. Informed consent was to be provided by the patient’s next-of-kin, but, in late December, an HREC representative alerted us to an imminent amendment to the Act which stipulated that only a guardian appointed by the Victorian Civil and Administrative Tribunal (VCAT) could provide consent to participate in “any procedure carried out for the purposes of medical research” on behalf of a disabled patient (in this instance, a patient with an altered conscious state). The Act does not further define medical research. Surveillance involves no intervention, and it is unclear to us (and some ethics committees) whether surveillance was considered a “procedure”. We indicated our uncertainty in a letter to VCAT in January 2003. If an application to VCAT were required for each patient we wished to enrol, then the study became unworkable. Under legislative requirements, VCAT is only obliged to “commence to hear” an application within 30 days of its receipt, which would prevent surveillance being conducted in a timely manner. Awareness of the legislative amendment differed between HRECs. In December 2002, two committees gave full approval for the study without reference to the amendment, while the remainder gave conditional approval, subject to complying with the amended Act. VCAT wrote to HRECs in February 2003 to clarify the amendment, and directly indicated to us that it did not apply to our proposed study. In May, despite the correspondence from VCAT, one HREC reaffirmed its position that applications must be made to VCAT for consent for studies such as this one. Despite attempts at clarification, a legislative amendment in Victoria has created ongoing confusion about obtaining consent on behalf of disabled patients. Researchers planning studies involving invasive procedures (eg, blood chemistry or seroprevalence studies) need to be aware of the amendment’s potential impact. Differences in interpretation of the amendment by the tribunal and various ethics committees highlight the need for further clarification of the Act, as well as for centralised and consistent assessment of HREC applications.

James E Fielding · Heath Kelly

Martin B Van Der Weyden Editor, Medical Journal of Australia, Locked Bag 3030, Strawberry Hills, NSW 2012. editorialATampco.com.au Comment: Fielding and Heath raise two issues. The first is the increasing barriers to the conduct of research as the law and Human Research Ethics Committees (HRECs) quite rightly ensure the safety of participants in human research. In the words of Cicero, salus populi suprema est lex (“the welfare of the people is the highest law”),1 but the law is not immutable. The confusion uncovered by Fielding and Heath over the implications of the amendment to the Guardianship and Administration Act 1986 may prompt legislators to re-examine the purpose of the Act in the context of research involving patients with “altered conscious state”. The second issue raised is more general. The plurality of HRECs’ interpretations of the amendment may be difficult to fathom by ordered scientific minds: data are data, so why the differences in HRECs’ opinions? These frustrating differences are the bane of researchers involved in multicentre research.2,3 The 1999 National statement on ethical conduct in research involving humans4 empowers HRECs to minimise duplication and allows for ethical and scientific assessments made by one HREC to be accepted by others.5 Nevertheless, HRECs value their independence and are unlikely to relinquish it to others easily.6 Various states are considering the feasibility of centralised ethical bodies,5 but bureaucracy moves cautiously and change is always slow.

Martin B Van Der Weyden

Steve Lontos,* Robert M Jones,† Peter W Angus,‡ Paul J Gow§ * Liver Transplant Registrar, † Director, Liver Transplant Unit, ‡ Director, Department of Gastroenterology, § Gastroenterologist, Austin and Repatriation Medical Centre, Studley Road, Heidelberg, VIC 3084 paul.gowATarmc.org.au To the Editor: We wish to report a case of acute liver failure associated with the use of a herbal preparation that contained several ingredients, including Cimicifuga racemosa (black cohosh). In January 2003, a 52-year-old woman was referred to our unit with acute liver failure. She had taken a herbal preparation for three months (for severe tinnitus), but ceased four weeks before admission. The preparation was made and provided by a pharmacist. The preparation was supplied in a 200 mL bottle and contained a mixture of the fluid extracts of Nepeta hederacea (ground ivy) 80 mL, Hydrastis canadensis (golden seal) 20 mL, Ginkgo biloba (ginkgo) 40 mL, Avena sativa (oats seed) 40 mL and Cimicifuga racemosa (black cohosh) 20 mL. According to the information supplied by the pharmacist, one gram of herb was contained in each 1 mL of extract, with the exception of golden seal, for which 0.5 g of herb was contained in each millilitre. The oats seed fluid extract was supplied by Southern Cross Herbal School (Gosford, NSW), and all other fluid extracts were supplied by the Herbal Extract Company of Australia (Sydney, NSW). The patient took a total of 600 mL over the 3-month period (7.5 mL bd orally as required). Before developing symptoms of liver failure, the patient had taken no other medications and had no risk factors for the acquisition of viral hepatitis. On arrival, she was deeply jaundiced but not encephalopathic. Liver span was reduced and there were no signs of chronic liver disease. The international normalised ratio was 3.0 (normal, 1.0–1.2), and she had serum concentrations of albumin, 26 g/L (normal, 35–50 g/L); bilirubin, 368 μmol/L (normal, < 18 μmol/L); alkaline phosphatase, 230 U/L (normal, 35–104 U/L); alanine aminotransferase, 1380 U/L (normal, < 55 U/L); and g glutamyl-transpeptidase, 134 U/L (normal, < 45 U/L). Extensive investigation excluded other recognised causes of acute liver failure. Her condition deteriorated over the following week, with the development of hepatic encephalopathy and hepatorenal failure. She underwent liver transplantation in early February 2003, and had an uneventful postoperative course. Examination of the explanted liver revealed massive hepatic necrosis. Following transplantation, the pharmacist supplied samples of the individual extracts to the Therapeutic Goods Administration (Canberra) for analysis. The analysis revealed no undeclared pharmaceutical drugs. Assay of the individual extracts of golden seal, ginkgo and black cohosh revealed the listed ingredients to be present. The presence of ground ivy and oats seed in the extracts has not yet been confirmed owing to the lack of a suitable reference standard. It is not possible to determine the individual ingredient, or mixture of ingredients, that resulted in acute liver failure in this patient. However, this is the third case of acute liver failure associated with black cohosh ingestion to be reported recently in Australia.1 In this instance, liver failure progressed despite cessation of the herbal therapy, and transplantation was required, suggesting that a process of irreversible liver injury had been initiated before treatment was ceased. It should be noted that ground ivy contains pulegone, a known hepatotoxin. However, the concentration of pulegone in ground ivy is accepted to be vastly less than in pennyroyal, where pulegone-induced hepatotoxicity has been reported.2 To our knowledge, there are no reports of golden seal, oats seed or ginkgo causing hepatotoxicity. The popularity of herbal therapies is due in part to their perceived lack of side effects. It is important for the medical and broader community to be aware of the potential toxicity of these preparations. In any patient presenting with unexplained hepatitis it is essential to determine if there has been exposure to herbal therapies, since early cessation of treatment may be life saving.

Steve Lontos · Robert M Jones · Peter W Angus · Paul J Gow

Michael D Coory Medical Epidemiologist, Queensland Health, GPO Box 48, Brisbane, QLD 4001. michael_cooryAThealth.qld.gov.au To the Editor: The randomised controlled trial associated with the Women’s Health Initiative (WHI) found that long-term hormone replacement therapy (HRT) with combined oestrogen–progestin causes net harm.1 Both the article by Baber and colleagues on HRT2 and a previous editorial by Patel and colleagues3 imply that the method used to calculate the confidence intervals in the WHI report is questionable. Baber et al suggest that “a trial such as this, with multiple endpoints, should use adjusted rather than nominal confidence intervals to test individual endpoints for significance”.2 It is important that this issue is clarified. In the WHI report in JAMA, Table 2 shows both nominal and adjusted confidence intervals for the primary and secondary outcomes.1 Nominal confidence intervals are appropriate for the preselected primary outcomes of the trial — breast cancer, coronary heart disease and the composite global-index score.4 Confidence intervals adjusted for multiple comparisons are possibly appropriate for the multiple secondary endpoints in the study, but are not advocated by all statisticians.5 In any case, the decision of Baber and colleagues to concentrate on adjusted confidence intervals for the preselected primary outcomes is not valid.4 The purpose of confidence intervals is to assess the effects of random variation or chance. It is not sensible to suggest that the extra harm that occurred in the combined HRT arm of the WHI study could be due to chance. Moreover, 42% of women in the HRT group stopped taking the drug, and 11% of women in the placebo group started taking it.1 Therefore, the reported findings of the intention-to-treat analysis underestimated the true harm to individual women taking long-term HRT. Also, if duration of treatment is important (as appears the case with breast cancer risk), and because compliance decreased over time, 5-year results underestimated longer-term treatment harm.4 The aim of the WHI trial was to assess whether long-term HRT is a useful preventive intervention for postmenopausal women. It did not assess the short-term use of HRT to relieve severe hot flushes. As Sackett points out, curative and preventive medicine are absolutely and fundamentally different in their obligations and implied promises to the individuals whose lives they hope to modify.6 As a long-term preventive intervention, HRT causes more harm than good. Although the absolute risks were small, millions of women were prescribed this treatment worldwide, causing harm to thousands. Billions of dollars were spent on an ineffective preventive intervention.6 The thousands of Australian women who stopped taking HRT on learning the results of the WHI trial made a sensible decision.

Michael D Coory

Rodney J Baber,* Justine L O’Hara,† Frances M Boyle‡ * Clinical Senior Lecturer, Department of Obstetrics and Gynaecology, University of Sydney, NSW, 2006; † Medical Student, ‡ Oncologist, Royal North Shore Hospital, Sydney, NSW. rbaberATmail.usyd.edu.au In reply: We acknowledge that not all statisticians agree on the place of adjusted confidence intervals. However, we and others1,2 believe they represent a conservative choice for secondary endpoints in a study with multiple endpoints, such as the WHI trial. Results of recent randomised controlled trials of hormone replacement therapy (HRT) and cardiovascular disease certainly support the notion that HRT confers no protection. However, any real harm of HRT must be questionable in light of the rapid review by Beral and colleagues, which, also using nominal confidence intervals, showed no change in relative risk for HRT users.3 We are surprised that, having emphasised the importance of nominal confidence intervals for primary endpoints, Coory did not mention that the breast cancer risk in the WHI report was not statistically significant using either nominal or adjusted CIs, or that the global index used was a non-validated instrument designed for and used only in the WHI study.4 Intention-to-treat analysis is used to avoid overestimates of both harm and benefit. While drop-in and drop-out rates (equal in both arms) may have led to underestimates of harm from HRT, they may also have led to underestimates of benefit, with no net change to risk–benefit assessment. The aim of the WHI trial was to assess the benefit or otherwise of long-term HRT on disease processes in otherwise healthy women. There seems little doubt that in the group of older, overweight, somewhat hypertensive, women enrolled in this trial the use of HRT was not beneficial. The aim of our article was to assess the case for and against HRT use.5 In reaching our conclusions, we drew on a broad range of published data, including, but not confined to, the WHI data. Our conclusions make it clear that we believe the use of HRT is primarily for short-term relief of symptoms during the menopause transition. However, we sought to defend the right of a small number of women to choose to continue HRT for long-term improvement of quality of life and symptom relief after appropriate, balanced, individualised counselling about the risks and benefits of such a decision. We do not agree with Coory’s final comment. The thousands of Australian women who stopped taking HRT on learning the results of the WHI trial did so in fear and ignorance in an environment where their physicians were unable to offer balanced counsel — hardly a formula for good medicine.

Rodney J Baber · Justine L O’Hara · Frances M Boyle

John Winter Ashton, an anaesthetist, died suddenly and unexpectedly on 29 November 2002 of a pulmonary embolism. His death was preceded by a short illness, which necessitated his retirement from practice. John was born in October 1931 in Melbourne. He was educated at Melbourne Grammar School, where he distinguished himself as a formidable “back pocket player” in the 1948–49 Australian Rules football premiership 1st XVIII. Influenced by his father, a surgeon, and mother, a nurse, he studied medicine at the University of Melbourne, graduating in 1955. After internship at Prince Henry’s Hospital, Melbourne, and a short stint in general practice, John commenced anaesthetic training in Albany, New York, in 1958. He later worked at the Croydon group of hospitals in England, and obtained his Fellowship of the Royal College of Surgeons’ Faculty of Anaesthetics from the Royal Postgraduate Medical School, Hammersmith, England, in 1963. John returned to Melbourne later that year to commence public and private anaesthetic practice. He was elected a Fellow of the Royal Australasian College of Surgeons’ Faculty of Anaesthetics in 1969. He was strongly linked to the anaesthetic department at Prince Henry’s Hospital and the Monash Medical Centre and heavily involved in the development of the Chair of Anaesthesia at Monash University. In the early 1970s, John’s determination to improve the status of anaesthetists led to his long association with the Australian Society of Anaesthetists (ASA). In 1982, he became Chairman of the Victorian Section of the ASA and in 1988 he was elected President of the ASA’s national body. John personified all that was best in the practice of medicine in general and anaesthesia in particular. He had the ability to establish instant rapport with everyone he met. His relaxed and warm manner concealed high technical skill and made it easy for him to teach others and provide reassurance to patients and surgeons alike. He was particularly known for his kindness and concern for those under his care. He was interested in many sports, but tennis, which he played with great skill and patience, was probably his major love. At least two members of Kooyong Tennis Club owe their lives to John’s resourcefulness when they collapsed on court. He was also a keen advocate of conservation issues and was never happier than on his property in the Dandenongs. John is survived by his third wife, Barbara; sons Gerard, Julian and Nigel; and stepsons, Craig, Sean and Stuart.

Rowan Blogg · Les R King · Bill P Lewis · Herb C Newman · Graham A Syme

Re the article “Quality of care provided by general practitioners using or not using Division-based diabetes registers”, by Mark F Harris, Debbie Priddin, Warwick Ruscoe et al in the 2 September 2002 issue of the Journal (Med J Aust 2002; 177: 250-252). In Box 3, the heading for columns 2 and 3 was incorrectly given as “Proportion of patients having at least one HbA1c test”. The heading should have been “Proportion of patients having more than one HbA1c test”. The html and pdf versions of the article have been corrected.

Mark F Harris DRACOG, FRACGP, MD · Fernando A Infante MB BS · Brian I O’Toole PHD, MPH · Debbie Priddin RN, BSocSci · Warwick Ruscoe MB BS, FRACMA

Re the editorial “Australian healthcare reform: in need of political courage and champions”, by Martin B Van Der Weyden in the 15 September 2003 issue of the Journal (Med J Aust 2003; 179: 280-281), the box was inadvertently omitted in the printed version of the article. The html and pdf versions of the article published online were correct. The article was reprinted in full on 6 October (Med J Aust 2003; 179: 339-340)

Mark F Harris DRACOG, FRACGP, MD · Fernando A Infante MB BS · Brian I O’Toole PHD, MPH · Debbie Priddin RN, BSocSci · Warwick Ruscoe MB BS, FRACMA

Charmed In chronic heart failure, a Lancet commentary advises that patients whose ejection fraction is 40% or less should be prescribed angiotensinreceptor blockers in addition to ACE inhibitors, β-blockers and/or spironolactone.1 Further, angiotensin-receptor β-blockers should be used as an alternative drug in patients with intolerance to ACE inhibitors, and considered in patients whose ejection fraction is more than 40%. The author was commenting on four papers reporting the results of the CHARM — the Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity — program.2 CHARM, involving more than 7000 adults with chronic heart failure living in 26 countries including Australia, found that the angiotensinreceptor blocker candesartan reduced cardiovascular deaths and hospital admissions for heart failure. 1. Lancet 2003; 362: 754-755 2. Lancet 2003: 362: 759-781 Horsing around Wearing a helmet while horse riding will protect the head and skull; however, it may not protect the rider’s neck, spine and face from injury, according to a study from Sydney’s Prince of Wales Hospital complex. Nevertheless, those who do not use a helmet are at greater risk of injury. The study analysed injuries occurring in 429 patients who presented after horse-riding accidents. Although more professional riders were represented among the injured, recreational riders were more likely to sustain a serious injury and require admission. Aust N Z J Surg 2003; 73: 567-571 Prescribing matters Vigorous debate abounds about whether direct-to-consumer advertising (DTCA) of drugs helps or harms patient health and healthcare systems.1,2 Now, evidence adds to opinion-based argument, with North American researchers saying that exposure to DTCA increases the rate at which patients ask for advertised drugs, but not doctors’ responses to such requests.3 The researchers surveyed 78 doctors and 1431 adult patients in primary care settings in Sacramento, California, where DTCA is legal, and in Vancouver, Canada — where although it is arguably illegal there is some exposure to DTCA. Patients in Sacramento were more likely to have seen ads for prescribed drugs, and 7.2% requested such drugs — compared with 3.3% of patients in Vancouver. The prescribing rate for patient-requested advertised drugs was similar in both cities — about 75% — despite frequent doctor ambivalence about choosing this treatment for other, similar patients. As well as having an effect on product choice, DTCA appeared to increase prescribing volume overall; however, the study did not evaluate treatment appropriateness. 1. www.nzma.org.nz/journal/ 116-1180/556/ 2. CMAJ 2003; 169: 425-427 3. CMAJ 2003; 169: 405-412 Unearthing the past Iraqi villagers near the city of Hilla recently used a backhoe to dig up thousands of human remains, gouging and commingling countless skeletons. US forensic and human rights experts have expressed concern about this and other, more official approaches to the exhumation of mass graves in Iraq — where 290 000 people have been reported missing over the past 20 years. They want a comprehensive strategy put in place that takes into account the legal needs of possible future criminal trials and the technical complexities of identification, as well as the humanitarian needs of the families of those who disappeared. JAMA 2003; 290: 663-666 Leave out the excess A meta-analysis of eight randomised controlled trials has suggested that, in the GP setting, screening for excessive alcohol use to find cases and then using a brief intervention is not an effective strategy. Only 25 in 1000 screened patients will qualify for intervention and only two or three of these are likely to benefit. BMJ 2003; 327: 536-542 "Terminal sedation" Dutch health minister Clémence Ross has drawn a distinction between euthanasia and “terminal sedation” that has been welcomed by doctors in the Netherlands, according to a news report in the BMJ. Euthanasia involves giving medication at a patient’s request that will result in his or her death in a short time; whereas terminal sedation is giving drugs that reduce consciousness in dying patients so that they are no longer aware of their surroundings and suffering. Ross was rejecting a call from the Dutch attorney general for euthanasia and terminal sedation to be covered by the same legal controls. The news report said a recent study suggested that up to 10% of all deaths in the Netherlands occur following terminal sedation. BMJ 2003; 327: 465

Ann Gregory