Editorials

Australia, like other high-income countries with a low TB incidence, faces special challenges in controlling TB Books with optimistic titles such as Triumph over tuberculosis, The retreat of tuberculosis and The miracle of empty beds were published in the 1970s and 1980s. Readers of the Journal may therefore be surprised to find six articles on tuberculosis (TB) in this one issue in 2008.1-6 Far from having dis-appeared, TB is the dis-ease that still affects the dis-placed, the dis-advantaged, the dis-possessed, the dis-rupted and those with dis-abled immune systems. Displaced persons and migrants accounted for 85.5% of the 1201 TB cases in Australia in 2006.7 Overseas-born TB patients commonly come from India, Vietnam, Indonesia, China and the Philippines. Sudan and Somalia have more recently joined this list, following the shift in Australia’s immigration policy to accept more African refugees. These national figures are reflected in the letter from Robinson et al, which describes a retrospective review of TB cases seen at The Children’s Hospital at Westmead, Sydney, between 2004 and 2006 (&rarr Tuberculosis in children: a tertiary centre perspective).5 Of the 23 children with active TB disease, 18 (73%) were born overseas, mainly in Africa and the Indian subcontinent. Compared with data from 1982–1991, the proportion and number of latent TB infections diagnosed in children had increased due to active screening of refugee populations. The article by Dobler et al highlights the successful outcome of directly observed treatment for TB cases in Australia, while alerting Australian doctors to the fact that migrants with treated TB who visit their TB-endemic country of birth may develop a second episode of TB that represents a new infection rather than a relapse of their previous disease (→ Recurrence of tuberculosis at a Sydney chest clinic between 1994 and 2006: reactivation or reinfection?).1 TB also affects the disadvantaged and dispossessed, as illustrated by the fact that the TB incidence in Australia’s Indigenous population has been 7–15 times higher than in the non-Indigenous Australian-born population over the past decade.7 TB affects those with disabled immune systems. People infected with HIV have nearly 10 times the lifetime risk of developing TB compared with HIV-negative people.8 HIV/TB coinfection is not considered a major problem in Australia, with only 11 HIV/TB patients identified in 2006.7 However, the national TB notification system recorded the HIV status of only 35.2% of TB patients in 2006.7 Emerson and Post rightly exhort Australian clinicians to offer HIV testing to all TB patients (→ To routinely offer testing for HIV infection in all cases of tuberculosis: a rational clinical approach?).2 In fact, establishing the HIV status of TB patients could be regarded as an expected standard of care. Other immunocompromising conditions — such as chronic renal failure, transplantation, or treatment with glucocorticoids or tumour necrosis factor α inhibitors — also increase the risk of TB reactivation twofold or more.8 For patients about to receive tumour necrosis factor α inhibitor therapy, Gupta et al propose a screening strategy for latent TB infection using an interferon γ release assay, such as QuantiFERON-TB Gold (Cellestis, Melbourne, Vic) or T-SPOT. TB (Oxford Immunotec, Oxford, UK) (→ Tumour necrosis factor α inhibitors: screening for tuberculosis infection in inflammatory bowel disease).6 The optimal application and interpretation of these assays is controversial. For example, although various versions of the QuantiFERON assay have been approved by the United States Food and Drug Administration and endorsed by the US Centers for Disease Control and Prevention, Australian and Canadian TB authorities are continuing to recommend the tuberculin skin test for diagnosing latent TB infections in most patient groups until the sensitivity, specificity and cost-effectiveness of interferon γ release assays have been better defined.9,10 Finally, like many other infectious diseases, TB affects populations that are disrupted or disorganised due to socioeconomic upheavals, rapid urbanisation, persistent poverty, conflict or war, and where public health systems are therefore either weak or non-existent.11 In a speech to the Lowy Institute in July 2007, Kevin Rudd (then Federal Opposition Leader) highlighted the “arc of instability” to Australia’s near north, noting the recent political unrest in East Timor and several Pacific Island countries and the continuing impoverishment in parts of Indonesia.12 The link between TB and this arc of instability is amply demonstrated by the articles in this issue about illegal foreign fishermen with TB (→ Tuberculosis in illegal foreign fishermen: whose public health are we protecting?)4 and people with multidrug-resistant TB from Papua New Guinea seeking medical care in the “Torres Strait Protected Zone” (→ Evidence of primary transmission of multidrug-resistant tuberculosis in the Western Province of Papua New Guinea).3 For example, Gray et al4 estimated the prevalence of all TB diagnoses among illegal fishermen screened in Darwin over a 15-month period to be 1360 cases per 100 000 population! How should Australia respond internally to this persisting TB problem? Limiting migration and ostracising migrants is not indicated, acceptable or practicable in the “global village” of the 21st century. We require migrants and temporary visitors for our economy, for plugging skill gaps in our workforce, and for nation building. Moreover, molecular epidemiological studies in Australia and overseas have demonstrated that there is negligible transmission of TB from migrant communities to the general population.13,14 The appropriate interventions are to optimise pre- and post-migration detection of active TB disease, to familiarise migrants with the TB clinical services that are freely available if they develop disease, and to detect and treat latent TB infections among subgroups of migrants who would benefit from this intervention (eg, children under 15 years old). The 2006 annual report of the National Tuberculosis Advisory Committee does highlight one migrant subgroup requiring particular attention by documenting that the number of TB cases among health care workers (HCWs) has risen from 34 in 2001 to 65 in 2006.7 This rise is attributable to the increasing recruitment of HCWs from high-incidence TB countries. There were no reports of TB transmission from HCWs to patients in 2006.7 Nonetheless, public and private health institutions, particularly those recruiting HCWs from high-incidence TB countries, must ensure that adequate TB screening is undertaken before and during employment. In common with other high-income countries with a low TB incidence, Australia faces special challenges in controlling TB.15 Continuing undergraduate and postgraduate education of medical and nursing personnel is required to ensure that health professionals remember to “think TB” in at-risk patients. Despite the low incidence of TB, federal and state governments must be encouraged to continue funding TB control efforts and must be dissuaded from devolving TB care from specialised TB services to general clinics in city hospitals. The closure of specialised TB services contributed to the TB epidemic in New York City in the 1980s and 1990s, which may ultimately have cost several billion dollars to control.16 The low incidence of TB may also discourage pharmaceutical companies from selling small volumes of anti-TB drugs at narrow profit margins in Australia, which is a geographically isolated market with stringent regulatory requirements. Federal administrators may need to develop novel solutions to ensure reliable anti-TB drug supplies into the future. How should Australia respond externally to the persisting problem of TB? As long ago as 1993, the TB problem was declared a global emergency requiring a global response. Rudd’s 2007 speech to the Lowy Institute proposed a new strategic partnership with our northern neighbours that emphasised proactive socioeconomic development and promised an increase in Australia’s official development assistance (as a percentage of gross national income).12 TB is one issue for which this rhetoric should become action. In responding to TB as a global emergency, Australia needs to provide direct continuing TB care in specific circumstances to foreign nationals, such as people with multidrug-resistant TB entering the “Torres Strait Protected Zone” and illegal fishermen entering Australian waters.3,4 Addressing only “acute life-threatening conditions” in these groups, as quoted in the article by Gilpin and colleagues,3 is short-sighted in view of the fact that TB is both communicable and potentially deadly. A collaborative approach is necessary in Australia’s border areas. More generally, Australia’s clinical and laboratory expertise in TB control could be harnessed to assist with national TB programs in neighbouring countries through properly funded bilateral partnerships. Such collaboration would be to our mutual benefit. Investment in TB programs in neighbouring high-incidence countries is one control strategy that has been largely ignored by high-income countries with low TB incidence. One analysis suggested that US-funded expansion of TB care into Mexico, Haiti and the Dominican Republic could reduce TB disease among migrants from these countries and would produce net savings for the US.17 The authors suggested that their findings could be generalised to other developed countries with large migrant intakes and should encourage those countries to fund TB control efforts abroad. TB really is where philanthropy and self-interest meet!

Ivan Bastian MB BS, PhD, FRCPA · Vicki L Krause MD, DTM

The need for stimulant treatment must be assessed regularly In a United States legal action in 2000 about educational neglect, Albany County judge G E Maney ordered the parents to resume administering methylphenidate to 7-year-old Kyle Carroll.1 At the time, this controversial ruling was understandable, because controlled trials of stimulant treatment (dexamphetamine and methylphenidate) for attention deficit hyperactivity disorder (ADHD) had consistently shown that stimulants reduce ADHD symptoms. The catch is that trials have examined short-term effectiveness (usually over less than 6 months), while ADHD is a chronic condition. In 1992, the US National Institute of Mental Health funded the Multimodal Treatment Study of Children with ADHD (MTA) to examine the long-term effects of routine community management versus carefully delivered treatments. Children with ADHD, combined type (that is, showing symptoms of inattention, impulsivity and hyperactivity), were randomly allocated to medication, psychosocial treatment, a combination of both, or standard community care. The medication group received treatment with methylphenidate in which an optimal dose was titrated, with blinding, to achieve maximum benefit. The psychosocial group received a variety of interventions that consisted of parent training, a summer treatment camp and classroom management. Those in the routine care group were given information about services and left to their own devices. In total, 579 children with a mean age of 8.5 years were randomly allocated to the four groups, about 145 in each. After 14 months, children in both the medication groups showed greater improvement than those in the behavioural treatment and community care groups, leading the authors to conclude that “carefully crafted medication management was superior to the behavioral treatment and to routine clinical care that included medication”.2 The results were influential in treatment guidelines3 and clinical practice. Participants were naturalistically followed up 1 and 2 years after the end of the trial. The results of the last follow-up (3 years from the onset of treatment), of 84% of the original sample of children (then aged 10–13 years), showed that none of the treatment groups differed on any of the five clinical and functional outcomes (parent- and teacher-rated ADHD and oppositional symptoms, reading achievement scores, social skills, and functional impairment).4 Also, there were no differences in substance use or delinquency, with the exception of a slightly lower rate of substance use among those in the psychosocial treatment group.5 While improvement had been steepest during the first 14 months (mostly in the methylphenidate group), this levelled off, and at 3 years, all groups showed a similar improvement; the methylphenidate group had not deteriorated but the other groups had caught up.4 Speculation is bound to follow these results, which have many ambiguities and nuances. For example, this follow-up was not part of the controlled trial and, as happens in practice, children switched on and off their medication over time in the various groups, with consequent difficulties for analysis and interpretation. The results highlight several issues. First, it suggests the Rolls-Royce model (medication plus psychosocial treatment involving the child, family, and school) is not more effective in the long run than any of the other treatments, including the often maligned community care. The combined treatment is seen as the ideal, but is rarely delivered in practice, because of high cost and the burden for parents and schools.6 Second, there seems to be a “growing out of” or developmental factor at work. Epidemiological7 and follow-up8 data have consistently reported a reduction in ADHD symptoms with increasing age — although some individuals continue to show problems. This is also consistent with findings that brains of children with ADHD, rather than developing abnormally (as in autism), mature later.9 The MTA did not include a placebo group, which might have led to the conclusion that regression to the mean or maturation itself were the reasons for improvement. If that was the case, it is possible that helping families and schools contain children’s ADHD behaviour during the middle and late primary school years with minimal interventions (eg, parent management training) may be enough for a proportion — but not all — of these children to get better, or for medication to be required mostly during this developmental period. Finally, the MTA confirmed that medication can cause retardation of growth, including weight, particularly during the first year of treatment.10 While results of one study rarely justify drastic changes of practice, the findings underscore the complexity of ADHD, show that stimulant drugs are far from being a silver bullet, and that there is much that we do not yet know. This does not mean that stimulants no longer have a place in the treatment of ADHD. However, that place has shrunk, and clinicians should be circumspect when assessing the need for ongoing treatment (eg, through medication breaks). Much needs to be done to clarify who benefits the most from medication, at what developmental point stimulants are most useful, and for how long they should be taken. It is also not known whether these results apply to the slow-release formulations (which may enhance adherence) and to atomoxetine (a non-stimulant drug with antidepressant activity, which is thought to act by inhibition of the presynaptic noradrenalin transporter). Parents, often caught in the bind of concerns about their children taking medication and fear of the consequences of not treating them, might be comforted by these findings. One wonders whether Judge Maney would have issued the same order to Kyle Carroll’s parents had he been aware of this information.

Joseph M Rey MB BS, PhD, FRANZCP

The new Australian surgical training program starts in 2008 The Council of the Royal Australasian College of Surgeons (RACS), with the support of the nine specialty boards and related specialist societies, has approved the new Surgical Education and Training (SET) program, to commence in 2008.1 The RACS has responded to drivers of change in medical education, the bottleneck of basic surgical trainees and a wish to move to a competency-based training program. There will be a single point of selection into one of the nine specialties for medical graduates who have completed at least their second postgraduate year. The training program will be 5 to 6 years, the duration depending on the specialty. The years of training will be called SET 1 to SET 6, with the Fellowship examination remaining the final exit assessment. Selection tools for all specialties include three components: a scored curriculum vitae, reports from mentors and referees, and a semistructured objective interview. The first round of selection was successfully completed in August 2007, with 1538 applications from 1000 applicants over the nine specialties. Applicants could nominate more than one specialty. Most reached the interview stage, and 472 offers were made (198 for SET 1 and 274 for SET 2); 80% of the positions were offered to current basic surgical trainees.2 Medical graduates and students can indicate their interest in surgical training by registering with the RACS in PreSET, an unstructured phase leading to selection into SET. Completion of the Australian and New Zealand Surgical Skills Education and Training (ASSET) course during PreSET will be compulsory. This course provides an educational package of required generic surgical skills.3 During the SET years, assessment will be largely formative and competency-based. It will test the RACS’s nine core competencies and will rely heavily on in-training assessment tools such as Mini-CEX (mini clinical examination) and DOPS (direct observation of procedural skills), with a structured performance management process, overseen by supervisors and trainers, who will have completed a prescribed course on assessment and management of trainees (SAT SET).4 A summative assessment involving a multiple-choice examination and an objective structured clinical examination will have to be completed in SET 1 or 2 before a trainee progresses. In addition, by the end of SET 2, trainees will need to have completed the skills courses: Care of the Critically Ill Surgical Patient (CCrISP), Early Management of Severe Trauma (EMST) and Critical Literature Evaluation and Research (CLEAR). Potential trainees contemplating a career in surgery will have to decide at a much earlier stage, usually as undergraduate medical students. To attract the brightest students, academic surgical departments will need to be innovative and raise the profile of surgery in the curriculum, a task that has proved difficult in the past. Some universities have met this challenge by proposing streaming students into programs with specific surgical modules in the later years of the course. Relationships with academic surgeons and universitiesFor the implementation of SET, the College is considering establishing its own university, and is evaluating other models, one of which is to form closer relationships with existing university surgery departments in curriculum development and infrastructure support and administration. Macquarie University has established a Master of Advanced Surgery program in neurosurgery and is negotiating with the RACS and the Neurosurgical Society of Australasia.5 Other ways that academic surgical departments can form closer relationships with the RACS is in the conduct of the courses, such as ASSET and SAT SET, by providing the venue, organisation, instructors and facilitators, with the added advantage of ease of access for trainees, supervisors and trainers in that institution. University surgical departments could consider providing a package for potential trainees from the undergraduate years through PreSET to selection into SET, giving their students an advantage and an almost guaranteed pathway into SET. The core business of academic surgical departments is research. SET provides a catalyst for undergraduates, graduates and trainees considering research projects, graduate diplomas and higher degrees. Because research and publications rate highly in scoring for SET selection, and the new policies and regulations require research as part of SET, clinical and laboratory-based research projects will be keenly sought after, and many will wish to undertake a Bachelor of Medical Science or higher degrees such as a Master of Surgery, Doctor of Medicine or the combined Fellowship (FRACS)–PhD program. Surgical departments in New Zealand have established a Master of Medical Science diploma, with 50% undertaken by dissertation and 50% by publication combined with research forums and surgical research networks.6 Training for academic surgeryThese initiatives by academic departments also provide trainees with the motivation to consider a career in academic surgery. Closer relationships among universities, the RACS and hospitals can also create the potential for young surgeons with an interest in an academic career to have infrastructure support, such as an administrative assistant or receptionist; acceptance into an existing clinical craft-group practice; operating theatre access; and an appropriate academic title. It is not surprising that when the Association of Surgeons of Great Britain and Ireland and the Society of Academic and Research Surgery met in a consensus conference in September 2005, the focus was on surgical training as the greatest opportunity for preparing young surgeons for an academic career.7 The private sector provides another opportunity. The Commonwealth Government has allocated significant funding and has established the Enhanced Medical Education Advisory Committee to explore opportunities for surgical training in the private sector, including surgical departments in private hospitals with university affiliation. SET is ready. Will academic surgeons and universities see this as an opportunity to go forward? Will they develop innovative programs for undergraduates, sponsor RACS courses, provide SET preparation packages, develop attractive research programs, form closer relationships with RACS and hospitals (public and private) to implement SET and serendipitously promote academic surgery as a career?

Bruce P Waxman FRACS, FACS, MRACMA

With three iron chelating agents now available, management options have substantially increased Outcomes in patients with thalassaemia major have been revolutionised over the past 50 years. Without transfusions, death usually occurred in the first decade of life. In the 1950s, transfusions were given to manage the symptoms of anaemia, which resulted in increased survival but significant morbidity. In the 1960s, regular blood transfusions were introduced to maintain relatively high mean haemoglobin levels in order to suppress the production of abnormal red cells in the bone marrow. This permitted good quality of life in childhood, but led to cardiac death from transfusional iron overload at a mean age of 18 years.1 Fortunately, the parenteral iron chelating agent desferrioxamine was also introduced in the 1960s, and its use to control iron load led to improved survival2 and reduced morbidity.3 Nevertheless, the difficult treatment regimen (subcutaneous infusion for 8–12 hours per night, 3–7 nights per week) resulted in poor compliance. Cardiomyopathy remains the most common cause of premature death in patients with thalassaemia,3 even in well chelated patients.4 The recent development of new magnetic resonance imaging (MRI) techniques (T2*) has allowed the assessment of tissue iron levels (albeit indirectly), including myocardial iron levels, and has increased our understanding of iron overload. The use of this methodology has demonstrated that practically all thalassaemia major patients with cardiomyopathy have excess cardiac iron. It has also shown that the conventional surrogate markers — liver iron concentration and/or ferritin levels — are not predictive of cardiac iron levels.5,6 Cardiac iron overload has also been observed in patients who were previously thought to be well chelated.5,6 The licensing, in 1999, of the oral chelating agent deferiprone as a second-line iron chelator was initially embraced as a relief for patients who could not tolerate desferrioxamine or had adverse reactions to it. Recent data demonstrate that deferiprone is more effective than desferrioxamine in removing excess cardiac iron7 and suggest that it may even be more protective of endocrine glands (eg, the pancreas, thyroid and gonads).8 The beneficial effect may be related to the characteristics of deferiprone, which has a low molecular weight, an uncharged molecule and favourable lipophilicity and is largely unbound to plasma proteins, enabling easy entry into all tissues. The use of deferiprone and desferrioxamine in combination has even been demonstrated to reverse established cardiomyopathy.9 The bottom line is survival. For ethical reasons, prospective studies of survival are not feasible, and in any case it would take many years to acquire meaningful results. Data from observational and retrospective studies must therefore be given due consideration. An Italian epidemiological, natural history study of 516 patients demonstrated a higher incidence of cardiac disease and cardiac-related deaths in a group of patients who continued on desferrioxamine (359 patients) than in a group who were switched to deferiprone (157 patients).10 The latter group experienced no de-novo cardiac disease or iron-related deaths. Reports from other centres are also indicating reduction in cardiac deaths over the past few years, which may be attributable to the use of deferiprone.11 Both chelators are needed because the value of desferrioxamine is limited by poor compliance with treatment, and, although deferiprone is well accepted, its use is limited by concerns about potential adverse effects, particularly agranulocytosis. Although the incidence of this complication is low, its potential occurrence necessitates weekly blood counts. Some patients also complain of the relatively large number of tablets that need to be taken in three divided doses daily. The article by Kidson-Gerber and colleagues in this issue of the Journal12 comes from a unit in which patients are offered optimal management with appropriate monitoring and treatment, including prescription of desferrioxamine and deferiprone (→ Management and clinical outcomes of transfusion-dependent thalassaemia major in an Australian tertiary referral clinic). The authors quantified compliance by comparing prescriptions written with the actual amount of drug collected from the hospital pharmacy. This confirmed that, on average, patients took only 50% of the desferrioxamine prescribed, and only 10% took it exactly as prescribed. Their report firstly confirms the relationship between acceptance of chelation therapy and morbidity, making it clear that acceptance and use of chelation therapy is crucial for satisfactory outcomes, and secondly demonstrates increased compliance with oral chelation therapy. Seventeen patients (mainly non-compliant with desferrioxamine therapy) were additionally prescribed deferiprone. Relatively few took the prescribed quantity of desferrioxamine, but most took the deferiprone, sometimes even more than prescribed, indicating “creep” on the part of the patients towards the more acceptable oral therapy. The therapeutic armamentarium has been further expanded by the recent licensing of the oral chelator deferasirox in Australia and a number of other countries. Deferasirox is a soluble tablet that needs to be taken only once daily and therefore has high patient acceptance. At adequate doses, deferasirox is equivalent to desferrioxamine in its ability to reduce liver iron concentration.13 It has produced some adverse effects, particularly a rise in creatinine levels, but overall its safety profile is acceptable. Prospective studies of its ability to remove cardiac iron are in progress. We need to ensure that all patients with thalassaemia major have access to MRI (to assess their myocardial iron load) and the full portfolio of iron chelation options. In developing countries, the treatments available will be strongly influenced by cost. If the newer oral agents can be shown to be at least as effective as desferrioxamine in preventing iron-induced morbidity, the higher cost of deferasirox may be offset by the reduced cost of managing complications secondary to poor tolerance of desferrioxamine treatment. With three chelating agents now available, the options for chelation management are significantly increased. Chelation therapy can now be tailored to individual patients based on the severity and tissue distribution of the patient’s iron load. Intensive chelation regimens, combining deferiprone and desferrioxamine, are now possible, and data on the various potential combinations of the three chelators are expected to be available in the near future. In summary, the management of thalassaemia major has improved significantly with the ability to monitor not only iron load but also the sites of iron loading, and because clinicians now have the choice of three iron chelators. It can be anticipated that mortality and morbidity will be further reduced and that life expectancy will approach the norm — especially for younger patients. However, as shown by Kidson-Gerber and colleagues,12 prognosis will be largely dependent on compliance with iron chelation therapy.

Vasili Berdoukas OAM, MB BS, FRACP · Bernadette Modell PhD, MB BChir, FRCP

After a decade of closures, a flexible approach is needed About one in three Australian women give birth outside metropolitan areas. Historically, most of these women have been cared for by general practitioner obstetricians and midwives in local hospitals. However, in recent years it has been difficult to recruit and retain midwives and doctors with the necessary skills to adequately staff many rural maternity units providing traditional models of care. Whenever any essential component of obstetric, anaesthetic, paediatric or midwife infrastructure has become unavailable, maternity units have been closed, and women in the area are required to travel to the nearest maternity centre instead. It is estimated that more than 130 Australian rural maternity units have closed since 1995.1 In this issue of the Journal, a description by Scherman and colleagues (→ The first year of a midwifery-led model of care in Far North Queensland) of the first year’s experience at Mareeba District Hospital’s midwifery-led maternity unit provides some interesting and valuable insights into the role of low-intervention birth units for low-risk women in rural areas.2 Women planning to give birth at Mareeba were screened for risk factors, and low-risk women were selected for maternity care provided by a midwife. Medical back-up was provided through regular case conferences with an obstetrician at the nearby Cairns Base Hospital, who also visited Mareeba once a month, and on-site back-up from local GPs, who were able to perform caesarean section delivery if necessary. Intrapartum transfer was rarely used and largely confined to primiparous women. The authors reported no significant preventable morbidity or mortality in mothers or their babies, and their findings would appear to support the feasibility of this model of care, especially for multiparous women — although they acknowledge that the number of births so far is too low to support any conclusions regarding safety. Intervention rates were significantly below state averages. In 2004, 207 women gave birth at Mareeba District Hospital under the previous model of care,3 and in the 12 months of this study (2005–2006), 147 low-risk women (plus 11 high-risk women) did so under the care of a midwife. Had the maternity unit been closed, these women would have had to travel over 60 km to Cairns Base Hospital for delivery, as did the 45 women who required transfer during pregnancy for pre-existing or emergent risk factors. Interestingly, the powerful sway of maternity care politics is evident. What other clinical discipline would employ three full-time and nine part-time staff in a dedicated unit with medical back-up to treat 203 patients a year, with an alternative facility 60 km away that ultimately treated almost a quarter of them anyway? The study by Scherman and colleagues raises several other significant issues. The low use of epidural anaesthesia (1%) — which required transfer to Cairns when requested — surely reflects the lack of access at Mareeba, rather than true patient preference. Although facilities for some caesarean deliveries are in place at Mareeba, it is not always possible to perform an emergency caesarean section on site. Recorded transfer times for unplanned deliveries at Cairns Base Hospital were 80–145 minutes, with transfer required either for epidural request or first-stage failure to progress. There is little evidence upon which to base recommendations for the optimum time interval between decision to transfer and emergency delivery, and perhaps transfer would be completed more urgently in a situation where delay could compromise the mother or baby, but most clinicians would agree that a shorter interval than those reported is desirable. A related issue is whether or not staff (both medical and midwifery) providing obstetric care at such units should also spend some time working in a higher-level unit, to maintain their skills in management of relatively rare complications. For example, the treatment of catastrophic life-threatening obstetric haemorrhage is rarely required — but will outcomes be optimal in units where this complication might only be seen by staff once every 5 or 6 years? A Cochrane review of outcomes at birth centres and medical-led units found a statistically significant higher perinatal mortality rate (relative risk, 2.38) in birth units staffed by midwives who did not also work in medically supervised hospital units.4 The search for models of maternity care best suited to women in rural areas will continue to challenge health service planners. A paradox haunts them: the more remote a maternity service is from a referral centre, the higher the perceived community value in keeping it open, but also the higher the risk in operating a low-intervention unit that can provide care for most low-risk women but which ultimately relies on emergency transfer of women with unexpected complications. It is noteworthy that 70% of women who develop pregnancy complications are classified as low risk on initial assessment.5 It seems likely that continuing provision of maternity services in rural areas will depend on optimum use of the local workforce and health facility infrastructure. Individual regional areas will need to come up with arrangements based on consultation with the local community and health workforce. This will require a flexible approach and should recognise that transfer of women may sometimes be required, because of temporary unavailability of a core of necessary staff. It is unlikely that a “one size fits all” approach will deliver solutions to all areas at all times. The key will be cooperation and consultation with the local medical and midwifery workforce, open disclosure to women of what services can and can’t be provided locally, and facilitation of transfer of pregnant women to referral centres if they so choose. Since the MJA’s acceptance of the review of the Mareeba Maternity Unit, reports of an intrapartum, apparently avoidable stillbirth have been published in the press. The incident is being investigated by the Health Quality Complaints Commission following an internal review.

Andrew F Pesce MB BS, FRANZCOG

Hand hygiene should be the highest priority In this issue of the Journal there is yet another article showing that methicillin-resistant Staphylococcus aureus (MRSA) can easily be found on environmental surfaces — this time on identity badges and lanyards (→ What's hanging around your neck? Pathogenic bacteria on identity badges and lanyards).1 This adds to an increasing array of items such as neckties, stethoscopes, pens, computer keyboards and coats that can be colonised by pathogenic bacteria (although usually only in low numbers). While it is helpful to know all the places we may find MRSA, these types of studies really just confirm what should be blindingly obvious — that MRSA readily disseminates within our health care environment. Thus, the hands of health care workers will frequently come into contact with MRSA. The real issue with the control of MRSA is not the need for more information on environmental contamination, but the need to use the abundant information we already have to curtail the principal way that MRSA spreads in hospitals — via the hands of health care workers.2-4 Our inability to adequately address the key issues2 means that, increasingly, others will intervene, sometimes with mistaken emphasis and priorities. The United Kingdom has just mandated a “bare below the elbows” dress code in its hospitals.5 This means no more coats or even wristwatches, despite a lack of evidence that these items play a major role in transmitting MRSA. The UK Prime Minister has called for better cleaning of wards, in the belief that this is the key to controlling MRSA.5 While there is some merit in these proposals, they are focusing on elements that are minor compared with the most important one — how best to stop MRSA spreading via hands. We already know more than enough to control MRSA.2 If we use regular hand hygiene procedures with alcohol/disinfectant solutions we can reduce serious infections caused by MRSA. Better screening policies will identify people carrying MRSA and help to keep them away from those not already carrying the organism. If we wear appropriate gowns and gloves when dealing with patients (especially those known to have MRSA), then clothing and other inanimate articles will less often become contaminated with MRSA. Having more single rooms in hospitals and reducing overcrowding in emergency departments and other areas will make it easier to separate patients with MRSA from those without. We need to follow “isolation” rules, such as preventing staff from bringing their own stethoscopes or other equipment into a room where a patient with MRSA is being cared for. If we use hand hygiene procedures before and after seeing each patient, even if our hands have been in contact with MRSA on an inanimate surface, any MRSA organisms should be killed before our hands transmit them to patients. The question is, how do we change our current work practices and behaviour to ensure that these important elements are followed, not just some of the time but all the time? We don’t need more environmental-type studies without clinical endpoints. We need studies in which we intervene and show that the interventions reduce the number of people infected with MRSA.3,4 Surprisingly, there are few such studies, which is likely a reflection of how we regard quality improvement (QI) programs. QI research is not “sexy”. It is often difficult to attract funding for QI studies and get them published, because the realities of clinical practice mean that it is frequently hard to control all variables. Nevertheless, it is peer-reviewed QI programs with successful interventions that are most likely to lead to long-term reductions in MRSA infections. MRSA is a major and increasing problem worldwide. Unfortunately, the extent of infections caused by MRSA is not measured consistently or accurately (and often not at all). Timely data are not readily available for the vast majority of Australian hospitals. In England, it was mandated in April 2001 that all MRSA bacteraemia episodes be notified.6 Data from individual hospital trusts are now accessible on the Internet.7 While making the data available has generated disagreements,8,9 this intervention coincided with the first sustained year-by-year fall in the number of MRSA bacteraemia episodes (from 7700 in 2003–04 to 6378 in 2006–07). In Australia, over 4500 episodes of health care-related S. aureus bacteraemia occur per year.10 Of those, about 2000 episodes involve MRSA, with a 35% mortality rate. We need the health care profession to better define the extent of disease caused by MRSA and other serious pathogens using practical and robust outcome measures.7,11 Data from a broad range of institutions need to be made available to enable meaningful comparisons, so that institutions with higher rates of infection can learn from their colleagues with lower rates. Hospital managers need to be part of this process. We also need to ensure that we not only measure what is going on, but, more importantly, do something about it.11 It is possible for us to achieve much better control of MRSA. Denmark, The Netherlands and Western Australia, for example, have kept the number of health care-acquired MRSA infections down to low levels.2 We know what the problem is. What we appear to lack is an understanding of human behaviour and the political and medical will to really do something about it. It is time to change. We have been missing the big picture for too long.

Peter J Collignon FASM, FRCPA, FRACP

The Journal’s priorities for health care under the new government are clear Curiously, during the recent federal election campaign, the health policy pronouncements of both the Labor and Liberal parties1,2 failed to address one of the major issues with the potential to affect the quality of Australia’s health systems, namely: progressive job dissatisfaction among health professionals. These health care workers must surely be utterly demoralised, for every day they are confronted by the deterioration, indeed, decay, of the systems in which they work and struggle to deliver high-quality care. Of prime concern to the public and health professionals is the systemic deterioration of our public hospitals, burdened as they are with ever-expanding waiting lists, reduced bed capacity, poorly coordinated clinical services, access block and overcrowded emergency departments.3 Add to this the stress of staff shortages, chronic underfunding and dysfunctional management, and it is easy to understand why our public hospitals scored so low in the recent Public hospital report card of the Australian Medical Association.3 This report provides an independent analysis of performance indicators such as bed capacity, access and equity, productivity and funding. Tellingly, all states and territories attracted criticism — not one escaped a pressing need for reform.3 So disturbing is this sorry state of affairs that one fears a repeat of the infamous Bundaberg Hospital scandal.4 Indeed, there has already been a flurry of distressing reports cataloguing near misses and clinical mishaps in emergency departments across the nation.5 General practice also has its share of problems. These include: increasing workforce shortages, especially in rural areas; the burden of red tape; inefficiencies in the interface between general practice and hospitals or community aged care; and numerous other issues related to continuity of care and access.6 And these difficulties will definitely be further stressed by the ageing of our population. With a newly elected Labor government, all Australians look forward to the inherent energy of a new government with a mandate for reform, expecting them to produce the best health system for all Australians. And for this to happen, both the new Health Minister and Prime Minister must be held accountable. The community has wearied of the cynical and perpetual denial of political responsibility and desperately longs for an enactment of Harry Truman’s dictum: “The buck stops here”. But this expectation has to be tempered by the need for plain speaking and honesty. It is deceitful for any government to promise the delivery of a Rolls-Royce health care system, but fund it as though it were an FJ Holden. As to the precise nature of the health reforms the government should pursue, there is a plethora of advice and recommendations.7-10 The Journal has only a few priorities: The present debate about federal–state government responsibility for health services should cease. We need a decision now about whether one level of government or two should be responsible for all Australian health care delivery, and the debilitating and destructive blame game should then cease. Preventive medicine should be given first priority. The inertia in tackling the obesity epidemic is an indictment of the profession and, in particular, the impotence of its public health sector. We desperately need enactment of a national policy with an array of incentives and penalties. In Indigenous health, the momentum engendered by the Northern Territory intervention needs to be sustained, in real partnership with Indigenous Australians. Patients and the public should have a stronger voice in decisions related to health care. To quote Peter Baume, a public health commentator and former Liberal senator and minister: [T]he agenda of the public is more important than the agendas of professionals and the groups that represent them. It would be great to have a system where difficult questions of resource priority were decided before citizen juries, instead of being decided secretly and off stage.11 Finally, changes in health need to involve doctors and return the practice of medicine to its appropriate focus: health care that is enabling and effective.12 Three principles should guide this reform: first, the goal at all times should be ensuring value for patients; second, changes in medical practice should be organised around medical conditions and care cycles; and, third, outcomes and cost should be measured.12 This tripartite approach is necessary to ensure that value for patients is achieved by a move from the current practice paradigm, focused on discrete, uncoordinated and episodic service delivery, to one characterised by integrated and coordinated care, wherein patients actively participate in their own management and are responsible for compliance with care plans.12 The role of organised medicine in Australia is to ensure that health reform is not only realistic, but is realised. It must be said, however, that any cynic, observing the system’s downward spiral, might reasonably question the strength of the profession’s advocacy role and political power. After all, the decline and decay in health care delivery has occurred despite professional protestations. Doctors’ advocacy must become more aggressive, and doctors need to become a politicised profession.13 We have had enough of commissions and inquiries! The time for talking is over. We need action. We need reform. Is the time not ripe for a united and independent task force — one with appropriate professional and consumer representation, which will ensure that the government remains on-task, pursues a reform agenda and reports widely on progress? Is it not time for doctors and other health professionals, who are arguably the only thing our health system has going for it, to question whether they should continue propping up a second-rate system that is jeopardising the quality of care and is increasingly of risk to patients? Doctors and their patients are resolved that the time for change is now. All expect the newly elected government to deliver. And soon.

Martin B Van Der Weyden MD, FRACP, FRCPA

The first 100 days after an election are full of enthusiasm, energy and chaos, and they are crucial to establishing the shape, style and content of the new government’s tenure. The electorate is eager for plans, changes and new ideas, and for election promises to become reality. Early action that is visible and accepted will secure the credibility of longer-term plans. Here, in an open letter to the new Health Minister, we state our hopes for Australian health and health care in that 100-day period Dear Minister, You have come to this task with a raft of policies and initiatives that you and your party have promised to implement, and you probably have a long list of ideas and issues that you want to address, or that others have lobbied for. In a previous issue of this Journal, we put forward eight challenges that we think you will face,1 and you have outlined your own list. Your first 100 days will be crucial, but please don’t rush into action. Take time to consider three fundamental things. First, what health system will be best for Australia in the 21st century, taking into account the health needs of all Australians and how the electorate wants its tax dollars spent? Second, what distinctive role can you, as the federal health minister, play to achieve that system and leave the nation healthier as a consequence of your term as minister? After all, you are accountable to all Australians for precisely such an achievement. Third, you need a strategy, so that your reforms and policies are not just isolated initiatives, but form a coherent plan that will ensure that current problems are addressed and health benefits are maximised. A carefully formulated plan is the difference between just replacing the cracked tiles on an old leaking roof and rebuilding the roof with a better design, updated technology and new tiles. The challenges you face are of two orders: issues that are now causing a huge increase in costs as their incidence grows (examples are chronic disease, childhood obesity, the uptake of new technologies and the workforce crisis), and others that are polity issues (such as the current dual — or should we say duel? — Commonwealth and state–territory funding streams, the public–private mix, and the focus on treatment at the expense of prevention, affordability and equity). It is the polity issues that demand that the “roof”, the protection that our nation’s health care system offers, is redesigned and brought up to date. Without such attention, there will be no sustainable solutions to the other issues that threaten to inundate us; a few new or recycled tiles just won’t do. We urge you to spend your first 100 days, first, planning several high-priority, national concerted actions in the three broad health service policy areas — prevention, community-based care and hospital services — and, second, developing national consensual mechanisms that will address the polity issues robustly and drive the concerted actions. Both these approaches, tackled simultaneously, are essential. United States Government Accountability Office The US Government Accountability Office (GAO) is known as “the investigative arm of Congress” and “the congressional watchdog”. GAO supports Congress in meeting its constitutional responsibilities, and helps improve the performance and ensure the accountability of the federal government for the benefit of the American people. GAO’s work includes oversight of federal programs; insight into ways to make government more efficient, effective, ethical and equitable; and foresight of long-term trends and challenges. GAO’s reports, testimonies, legal decisions and opinions make a difference, for Congress and the nation.2 You have promised a national health and hospitals reform commission, which will meet in the first 100 days of government. While requiring a broader focus than so far described, this commission could give you the expert support and consultative mechanisms needed for comprehensive and robust planning. Your initial success will be measured by the key performance indicators — cooperation and buy-in from the states and territories, non-government organisations, the private sector, health professionals and the public. At the end of 100 days, there must be evidence of a strong developing consensus and growing public confidence that you will stop the blame and cost-shifting of the past and create a new health system to meet national needs. But the gloss of these early glory days will last only if there are long-term commitments of resources to planning, infrastructure (including more effective e-health systems), the workforce, and research and development; to making patients’ experiences and outcomes central to health care decision making; and to monitoring and evaluating the effects of health-policy changes on health, so we know what is working and what is not. This last point is crucial to your long-term success. So we also propose that you establish an office of accountability for health to ensure that you and your partners in health planning and reform can know that agreed outcomes are being achieved, and the public can know that their tax dollars are wisely invested. The United States Government Accountability Office is a good model (Box).2 We offer here two of many reasons why we need the equivalent of the US Government Accountability Office. The cost of medical errors in Australia is over $1 billion annually and could be as high as $2 billion.3 About half of all medical mistakes are preventable.4 The current failure to collect comprehensive national data means that our progress towards better quality and safety remains anecdotal. The Editor of this Journal has spoken out on the failure to clearly enunciate and implement a comprehensive range of relevant safety indicators, mandatory incident reporting and learning systems for mishaps, and an outcome measurement system, stating that “Australians deserve better than this”.5 We agree. The cost of obesity in Australia last year was $21 billion in ill health and disability, premature death and productivity losses.6 Over 3 million Australians are obese, and this could rise to over 7 million people within 20 years if current trends persist unabated and unaddressed.6 The last Australian Schools Health and Fitness Survey was conducted in 1985, and the last National Nutrition Survey in 1995. This means that policymakers are hindered by the lack of current data to inform the development of new policies. Without ongoing measurements and feedback there is no way to evaluate the effect of implemented policies. It is only through repeated surveys, done by the same people using the same survey instrument, that we are able to assess progress and evaluate the success of individual initiatives. The overwhelming impression left from the election campaign is of 6 weeks of piecemeal policies, and local funding commitments that add to the multitude of health programs but do not strengthen or reform the health system. Your task now is to build a better health system that can deliver better health programs more effectively and efficiently. The multiple challenges must be tackled, with a focus on better health outcomes and better value for money. They can only be resolved by a shared national vision, national leadership and national action across a period that may encompass decades, but your actions in the first 100 days and investments in the first 3 years will be critical. This surely is where the Australian Government must play its main role and where a committed Health Minister can make a real difference and leave a lasting legacy. Since 1933, when Franklin Delano Roosevelt tackled the worst effects of the Great Depression in a rush of breathless reform,7 the first 100 days of a new government have provided the test of its leadership and reformist credentials. Australian state government leaders, from Jeff Kennett in Victoria to Geoff Gallop in Western Australia, have adopted this benchmark for achievement. We strongly advise you to embrace this benchmark, and we wish you well in the 100 days ahead.

Lesley Russell BSc(Hons), BA, PhD · Stephen R Leeder AO, MD, PhD · Bruce K Armstrong AM, DPhil, FRACP · James A Gillespie BA, PhD · George L Rubin FRACP, FAFPHM

Australian health systems must rise to the challenge of providing thrombolysis to more stroke patients The substantial benefits and relative safety of tissue plasminogen activator (tPA) for acute ischaemic stroke within 3 hours of symptom onset have been accepted by stroke clinicians around the world.1 It is one of the most effective treatments in acute medicine, with a 30% increase in excellent outcomes and a “number needed to treat” for clinical improvement as low as three patients.2 A European register of 6483 patients (SITS-MOST, Safe Implementation of Thrombolysis in Stroke Monitoring Study) indicated that tPA is safe and effective, even when used in relatively inexperienced centres.3 The clinical benefits overwhelm a small rate of bleeding complications, chiefly symptomatic haemorrhagic transformation of the infarct. The rate of symptomatic intracerebral haemorrhage was actually lower in this large register than in the earlier randomised clinical trials.3 Small Australian tPA audits have confirmed these conclusions.4,5 Based on level 1 evidence, the therapy was licensed in Australia in 2003, and is recommended in Australian, North American and European stroke guidelines.6 However, despite this overwhelming information, probably some thousands of Australian patients are effectively denied tPA each year.7 This is a major challenge for our health system. Batmanian and her colleagues have made an important contribution,8 demonstrating that a 24-hour comprehensive protocol delivered by a team involving emergency physicians and stroke neurologists can deliver thrombolysis to 14% of their acute stroke patients (→ A protocol-driven model for the rapid initiation of stroke thrombolysis in the emergency department). This figure is in line with the best international stroke centres. The involvement of emergency physicians is essential to optimise the delivery of tPA, particularly given the worldwide shortage of stroke specialists. With a protocol aimed at rapid triage, assessment and investigation of stroke patients, Batmanian et al have shown that nearly all eligible patients can receive thrombolytic therapy. Their centre at St Vincent’s Hospital (Sydney) and other Australian centres are participating in the ongoing SITS international registry, aimed at auditing the efficacy and safety of tPA for acute stroke. Nearly 400 Australian patients have now been entered on this registry, with safety of tPA consistent with the benchmark European figures (Dr M Parsons, neurologist, John Hunter Hospital, Newcastle, personal communication). A key barrier to the use of tPA is delayed arrival to hospital after stroke onset. In the St Vincent’s study, 40% of patients arrived within 3 hours, a higher rate than in many centres. Improved access to tPA and other acute stroke therapies can be enhanced by public education about stroke symptoms (such as the FAST: Face, Arm, Speech, Time campaign of the National Stroke Foundation in Australia), followed by rapid ambulance transport to a hospital with an organised acute stroke team. The public must be educated to call an ambulance, not a general practitioner, when stroke symptoms occur. Australian studies have confirmed that ambulance officers can accurately diagnose most strokes.9 Ideally, paramedics inform the emergency department of their impending arrival, facilitating the 60-minute “door to needle” target time for tPA therapy. Implicit in achieving good outcomes after therapy is rapid access to a stroke care unit (SCU), the benchmark for optimising outcomes in a condition with a high mortality rate and the commonest cause of disability in our society.10 Stroke strategies in most Australian states have been developed to increase the access of acute stroke patients to SCUs, which are expert multidisciplinary and geographically localised units, using evidence-based protocols for acute stroke therapy. In Australia, these are generally not intensive care units (ICUs), although cardiac monitoring is desirable during the acute period. In the St Vincent’s study, patients were monitored in the ICU for up to 24 hours, because the protocol mandated a 1 : 2 nursing care ratio. We generally admit tPA patients to our SCU during or after the initial 1-hour infusion in the emergency department. Our SCUs use a 1 : 4 nursing ratio. We do not consider that ICU management is needed for most patients, but acknowledge that differing models will suit different institutions. Acute reperfusion therapy is the most promising approach for acute stroke. The evidence for efficacy of tPA within 3 hours is overwhelming, although there is still some debate about treatment in the very elderly, patients with very severe neurological impairment, or those with extensive early ischaemic changes on computed tomography (CT) scan. Meta-analysis of the tPA trials shows that there are treatment responders beyond 3 hours. A number of trials, such as the ECASS 3 and the IST 3 trials, are aimed at extending the current time window for intravenous tPA. Intra-arterial thrombolysis or mechanical clot retrieval may be alternative approaches for selected patients who do not respond to tPA within 3 hours, or within later time windows.11 Thrombolysis is based on the recanalisation of occluded arteries and reperfusion of the ischaemic penumbra, a region of injured brain that is potentially salvageable with rapid restoration of blood flow. Identification of the penumbra using magnetic resonance imaging or perfusion CT may also allow individualised therapy at longer windows.12 In 2007, we do not recommend routine use of intravenous tPA beyond 3 hours, but strongly encourage Australian clinicians to enrol patients into trials addressing these hypotheses. Intravenous tPA is relatively simple to use, particularly with an effective partnership between emergency physicians and stroke clinicians, using appropriate protocols and stroke unit care. It is highly effective and relatively safe. In the 12 years since it was proven, the major systems failure in most countries has been delivering it to more patients. In Australia, we should not shirk from this challenge.

Stephen M Davis MD, FRACP · Peter J Hand MD, FRACP · Geoffrey A Donnan MD, FRACP

The Queensland approach may deliver empirical evidence on whether performance monitoring leads to improved quality of care Several high profile medical disasters have occurred recently in Australia and England and have raised concern about quality of care and patient safety. In Australia, the major disasters have included those at the Bundaberg Hospital in Queensland,1 and the Campbelltown and Camden Hospitals in New South Wales; and in England, the Bristol Royal Infirmary scandal2 and the Shipman Affair.3 Although the specifics in each instance are unique, a common outcome from the subsequent inquiries has been a recommendation for some form of centralised performance monitoring using routinely collected data. Why? Because retrospective desktop analysis of routinely collected data signalled the medical disaster before the “whistle blew”. What is interesting about Queensland Health’s response to the Bundaberg scandal, as described by Duckett et al in this issue of the Journal,4 is that these workers have combined their preferred casemix-adjusted statistical analysis (variable life-adjusted display [VLAD] plots) with an explicit protocol for action (→ Identifying variations in quality of care in Queensland hospitals). In so doing, Duckett et al have recognised that the ultimate purpose of data (and analysis) is to guide action5 (for improvement) while avoiding the commonly held casemix adjustment fallacy.6 The casemix adjustment fallacy begins with a deceptively simple equation that informally relates the variance in outcomes (eg, mortality) to a combination of three variables — chance, patient casemix factors, and quality of care. Statistical techniques are used to account for chance and patient casemix factors. The residual unexplained variance in outcome is then prematurely assigned to quality of care.6 This is naïve, because it assumes too much and is an oversimplification. For example, it assumes that the outcome variance equation is of a closed form (three variables only, when we have no basis to conclude this); it assumes perfect data (no errors in data, no measurement error) and perfect casemix adjustment (when we know that important casemix variables are not as yet measured or measurable); and, finally, it fails to recognise that all statistical models are but simplified approximations subject to error. This casemix fallacy — where the residual unexplained variance in outcome is automatically attributed to quality of care — is to be diligently avoided7 if the process of monitoring is to remain credible and useful in improving quality of care. The protocol for action developed by Duckett et al has two key characteristics: use of a pyramid model of investigation,6,7 which recognises that, in searching for assignable causes of variation, a useful strategy (which mitigates the casemix adjustment fallacy) is to systematically check five variables (data, patient casemix, structure, process of care, and carers), underpinned by an explicit clinical governance framework. A key feature of the pyramid model of investigation is the prior degree of belief, for which there is empirical evidence,8 that the vast majority of explanations for unusual variation will be located at the base (data, patient casemix) and the least likely explanations will be located at the apex (quality of care and carers). Indeed, as part of the Shipman Inquiry, two general practitioners were flagged as having “unacceptably” (the casemix adjustment fallacy) high casemix-adjusted death rates. Application of the pyramid model of investigation aided the discovery that this excess mortality was credibly explained by the numbers of patients in nursing homes — place of death was not included in the casemix adjustment method. Furthermore, the inclusion of data (at the base of the pyramid) ensures that data improvement is an integral part of any monitoring process, as this is usually a highly cost-effective way of reducing variation, to the benefit of all concerned. So it is a matter of concern that Duckett et al found that data improvement was frequent and “frustrating to hospitals and clinicians”. One reason for this frustration is because concepts such as “true positives” and “false positives” from diagnostic testing are applied to performance monitoring — but this is unhelpful and misleading. Consider, for example, a signal of high mortality which is due to a data error. If we predicate the definition of signals of special cause variation on malpractice or quality of care,9 then we are required to concede that a false-positive signal has occurred. But the notion of a false positive in the evaluation of a diagnostic test is based on a comparison with a reference “gold standard” test, by which the “true” disease state of each patient is known (albeit using the gold standard). In contrast, in performance monitoring, there is no gold standard and the true state of each data point is unknown, so the notion of false-positive signals makes little sense. Furthermore, in diagnostic testing, a false-positive result can mislead us into taking the wrong action, whereas finding and fixing a data error actually moves us in the right direction — towards understanding and eliminating special causes of variation.10 The possible confusion with diagnostic testing should be remedied through clarifying the purpose of monitoring and providing training on the method and its limitations. Duckett et al have adopted VLAD plots, which are simple visual tools for displaying variation. They show the indicator of interest one patient at a time, while accounting for the prior risk (casemix adjustment) and the play of chance as indicated by upper and lower limits. It is important to appreciate that, wherever the limits are set (except for 0 or infinity), we will occasionally commit an error of commission (when we wrongly identify a signal from the noise) or an error of omission (when we fail to detect a true signal from the noise). The choice of limits is, as Duckett et al state, a matter of judgement that is informed by statistical theory, economic consideration, and empirical evidence. What is exciting about the Queensland approach is that it is well poised to deliver the oft-lacking empirical evidence (because most monitoring systems do not include a specific action protocol) on the use of a performance monitoring system. This empirical evidence is the ultimate criterion by which to judge the usefulness of the performance monitoring system itself. As Duckett et al recognise, performance monitoring is the search for signals of variation from background noise in the presence of imperfect data, imperfect casemix adjustment, and imperfect methods of action. Although the performance monitoring system must be alert to “bad apples” (and this is noted in the pyramid model for investigation), care needs to be taken to ensure that the search for “bad apples” does not become the primary aim, as this will (most likely) increase fear and thereby hinder genuine continual improvement.9 Ultimately, performance monitoring needs to embrace the wider aspects of the science of improvement,9 in which statistical methods for analysing variation are but one component. The other major components involve “appreciation of a system”, “theory of knowledge” and “psychology of humans”, in which all stakeholders in the performance monitoring system cooperate towards the aim of continual improvement. The challenge for performance monitoring in general6,10 has been that it has itself been at variance with key principles of the science of improvement, and so the extent to which the Queensland model delivers continual improvement remains to be seen.

Mohammed A Mohammed PhD · Andrew J Stevens

Provision of incorrect information or incorrect data interpretation does not serve anyone well In this issue of the Journal, MacKenzie and colleagues present data to show that, over an 18-month period, media reports about prostate cancer were dominated by statements emphasising Australian men’s risk of prostate cancer, encouraging screening for early detection, and providing reassurance about side effects for treatments that emphasise emerging technologies (→ "The news is [not] all good": misrepresentations and inaccuracies in Australian news media reports on prostate cancer screening).1 In particular, they draw attention to rhetoric that unequivocally supports screening, which would seem to be irresponsible, given the lack of definitive data to show that population-based screening will reduce mortality. Although this is a fair comment to make, the enthusiasm with which the media has responded to the call to promote screening should not take anyone by surprise. Prostate cancer is the most common internal male malignancy in Australia and the second most common cause of cancer deaths in men.2 In 2003, there were 13 526 new cases of prostate cancer and 2837 deaths. By contrast, in that same year, 11 788 women were diagnosed with breast cancer and 2710 died of this disease. Although the biology of these cancers may differ, from the lay public point of view it is a “line ball” call. Little wonder then that, in the face of seeming inaction by government, consumer advocacy groups and some clinicians find a willing media to enter into a discourse that promotes action. In the context of a disease with a high community and individual burden, uncertainty about effective management plans and with no clearly articulated national public health strategy in place, advocacy such as this may be inevitable. A particular characteristic of this debate has been the polarisation of views for and against screening to the point where, at times, constructive debate has been constrained. However, it is important to differentiate between prostate-specific antigen (PSA) screening, with indiscriminate testing of all men (between prescribed ages), and testing after informed consent, as recommended by peak Australian cancer control and health agencies.3-6 Apart from the fact that PSA is not a test for prostate cancer and has no threshold level providing a high sensitivity and specificity, but rather has a continuum of prostate cancer risk at all values,7 a raised PSA level often commits men to the invasive procedure of transrectal ultrasound (TRUS) guided biopsies. Most men presenting for TRUS biopsies have serum PSA levels of 4–10 ng/mL and do not have prostate cancer detected with extended numbers of biopsy cores. If the diagnostic process were non-invasive and treatments with curative intent were not associated with significant unwanted effects, few would quibble about whether it is appropriate to be tested. Although estimates vary, there is no doubt that many men having treatment with curative intent are unlikely to benefit in terms of survival.8-10 Problematically though, such men are at risk of physical and psychosocial adverse effects from treatment that will affect both them and their partners.11,12 As a consequence, there is increasing support for stratifying patients, with an active surveillance protocol advocated for men identified as having low-risk prostate cancer.13 One expert advocates an intense monitoring protocol to identify the minority of low-risk patients (about 30%) with unappreciated aggressive disease for whom definitive therapy should be considered.13 However, this strategy can be undertaken only after biopsy diagnosis. There is no doubt that timely intervention does save lives. However, at the outset, men need to be fully informed of the possible adverse effects of potentially curative treatments and then consider whether, in the event of an abnormal PSA result and subsequent prostate cancer diagnosis, they would wish to proceed to treatment. Only then should they have a PSA test. Nomograms indicating cardiovascular life expectancy accurately may have a role in the future to allow a more tailored approach to overall management, including whether to proceed with prostate cancer testing. MacKenzie et al call for health authorities to commission and promote decision aids to assist men in making an informed decision about PSA testing for the early detection of cancer.1 Such decision aids already exist in a wide range of formats and have been shown to improve men’s understanding and knowledge about prostate cancer and to reduce decision-related conflict, although they have little effect on actual testing behaviour.14 The current need is not to develop more decision aids, but to translate shared and informed decision making about prostate cancer testing into primary care, the place where the decision to test is enacted.15 Barriers to translation include time constraints in busy general practices, general practitioner concerns about medicolegal risks, and GPs’ own knowledge and attitudes to prostate cancer testing. To address these barriers, a consortium, led by The Cancer Council Queensland and including The Cancer Council Australia, Australian Prostate Cancer Collaboration, Urological Society of Australia and New Zealand, and the National Cancer Control Initiative, developed an educational program and decision-aid showcard to support shared decision making about the early detection of prostate cancer in primary care.15 With funding from Andrology Australia, these materials are now available online, and uptake from general practice has been steady, with positive review by users.6 Importantly, the Prostate Cancer Foundation of Australia, as the leading prostate cancer consumer group in Australia, has been included in this initiative. This has been an important step in moving towards a constructive dialogue about this contentious issue. Whatever strategies emerge in terms of diagnosis and treatment in the future, provision of incorrect information, incorrect data interpretation or adverse consequences of the editing process itself do not serve anyone well, least of all patients and their relatives. Moreover, the task of supporting informed patient decision making is made more difficult when having to address misconceptions that may be derived from such reports. Articles such as that by MacKenzie et al highlight the need for media spokespeople to ensure that public discussion of prostate cancer is directed towards a realistic representation of the current status and limitations in relation to PSA testing and prostate cancer management in this country.

Suzanne K Steginga PhD · Robert (aka Frank) A Gardiner MD, FRCS, FRACS

Regulation of tobacco products and their emissions is long, long overdue The modern cigarette is an unmitigated public health disaster, more so than tobacco used in any other form. Together with other types of tobacco product, cigarettes are responsible for several million global deaths annually and expected to cause about 10 million annually by 2030.1 Modern cigarettes are uniquely efficient nicotine delivery devices because of sophisticated technology that controls such elements as pH and droplet size, and consequently provides rapid absorption and a rapid nicotine “fix” while using less tobacco, but many more additives, than its Second World War predecessor.2 Australia is at the forefront of the battle to control diseases caused by tobacco through the use of regulation of marketing and vigorous antismoking campaigns. The result is that “only” about a fifth of Australians smoke, and index diseases such as lung cancer and heart disease are declining in prevalence. There is, however, a strong social-class factor evident among continuing smokers, with the less educated and less well remunerated being over-represented in this population.3 Given Australia’s exemplary role in the regulation of cigarette marketing, it is bizarre that no regulations at all are applied to the product or its emissions. In this respect Australia is no different to most other countries as, apart from meaningless restrictions on tar, nicotine and carbon monoxide in Europe, no country worldwide has established control over cigarette emissions. A potential exception may be the United States, which currently has a bill before Congress that would empower the Food and Drug Administration to regulate cigarette emissions. The World Health Organization is moving to change this with its publication, The scientific basis of tobacco product regulation.4 This technical report sets out a practical rationale for regulating tobacco smoke, and makes specific recommendations for setting upper limits for two of the best understood carcinogens, the tobacco-specific nitrosamines, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and N-nitrosonornicotine, with the indication of more proposals to follow, plus discussions of design features that contribute to toxicity and marketability, such as candy flavourings, and recommendations for future research. Consumer products of virtually all types are regulated. Controls apply to almost every marketed product, from the proportion of rat droppings permitted in wheat, to the amount of fat allowed in sausages, and even to the amount of mint allowed in nicotine replacement therapy. With this background, it seems astonishing that the federal Minister responsible for drug and alcohol policy recently rejected claims that a new tobacco product (a “heatbar” which heats but does not burn tobacco) should be subject to regulation and said there were no plans to even investigate the product.5 This product is unlikely to be any worse than other tobacco products. It may even be an improvement, but we won’t know if it is not to be investigated. There seems to be a general view that all cigarettes are dangerous, which is true, but also that they are all virtually the same. Not true. Nitrosamines, for example, are potent carcinogens whose level can readily be reduced, almost to the point of elimination, by the manufacturers, but this would increase production costs and the tobacco industry is moving very slowly, in most places not at all, to reduce them. A global analysis of the Philip Morris brand, Marlboro, in 1996 showed a ninefold variation in the amount of NNK per cigarette.6 This would be unremarkable if it was merely a flavouring agent. However, it is a carcinogen and such unnecessary variation should not be allowed. Most industries would move in this direction voluntarily, but the tobacco industry long ago gave up trying to make cigarettes “safer”.7 Instead, their research has focused on ways to make nicotine better absorbed, and for cigarettes to be more flavoursome as well as less harsh.8 The need to regulate the constituents of cigarette smoke is not trivial. With one in five Australians still smoking, and with even higher proportions among the blue-collar end of the social spectrum, the tobacco-associated death rate will remain unnecessarily high. It is high time to regulate to reduce those major toxins and carcinogens that can be reduced, as this is one way to help continuing and addicted smokers. The WHO has led the way and will continue to recommend practical changes. Countries as sophisticated as Australia should be able to move ahead of other less developed countries and, in the case of a new and untested product, could be expected to do so as a matter of urgency. The Australian Government should recognise the WHO recommendations and set in train a process of tobacco regulation — one that is flexible and can be updated as the WHO continues to develop its regulatory program. This would be consistent with the approach taken to both pharmaceuticals and other consumer products, and is very long overdue. Now that the WHO has set out a practical approach, the federal government has few excuses for further delay.

Nigel J Gray FRACP

The absence of information on immunisation after the age of 7 years leaves a public health void The Australian Government currently funds the Australian Childhood Immunisation Register, including financial incentives for vaccine providers and parents, to update and record vaccinations given to children up to 7 years of age.1 The register provides information enabling appropriate updating of vaccination status for young Australian children. It also provides invaluable data on immunisation coverage, allowing ongoing evaluation, at a population level, of implementation, impact on disease, and vaccine safety for current childhood vaccination programs. However, this information is not available for vaccines administered after 7 years of age, the number of which is steadily increasing with the availability and funding of new vaccines as part of the National Immunisation Program. In 2007, a separate register was developed for human papillomavirus vaccine. But, in the absence of a register for other vaccines administered after age 7, providers, clinical researchers and assessors of program implementation must rely on self-reported vaccination status or on locating vaccination records. In some other countries there are alternatives for accessing data on vaccination status at a population level (eg, the records of health maintenance organisations providing private health cover for sub-populations in the United States,2 or population-based linked databases such as a government-run initiative in Catalonia, Spain3), but none exist at present in Australia. In 2006, the Australian Government Department of Health and Ageing announced a scoping exercise to examine the need for a “whole-of-life” immunisation register.4 It is illuminating to consider some key points informing this important debate relating to vaccination of elderly Australians. These have included the potential impact of relying on self-report to vaccinate elderly Australians, as well as improvements in program evaluation and opportunistic vaccination that might occur with the introduction of an expanded immunisation register. Influenza vaccine and 23-valent pneumococcal polysaccharide vaccine (23vPPV) have been funded in Australia for people aged ≥ 65 years since 1998 and 2005, respectively. They have proven benefit against confirmed influenza and invasive pneumococcal disease in this age group. Yet current assessment of coverage achieved by the program is limited to annual telephone surveys based on self-reported data from about 1000 people from each jurisdiction, and excludes residents from institutions such as aged-care facilities.5 Adverse events are reported via passive surveillance to the Therapeutic Goods Administration. Such an approach is likely to provide much poorer population estimates than accessing an effective register for the entire population. In addition, providers vaccinating individuals must continue to rely on self-report or location of vaccination records, and there is no facility for evaluating program implementation in other recommended at-risk groups such as Indigenous adults. The most recent of two Australian studies examining the validity of self-reported 23vPPV and/or influenza vaccination status in elderly people, which included almost 3000 Victorians, confirmed that self-report is problematic.6 Compared with provider-confirmed dates of influenza vaccination in the previous year, self-report had low specificity (56%) and over-estimated true coverage by 10% (86% versus 76%) — estimates that fall within the range provided by earlier studies.7-10 Estimates for validity of self-reported 23vPPV status in the previous 5 years (76%–85%)7 are also consistent with these earlier studies. Further improvements in vaccination coverage for elderly Australians with 23vPPV and influenza vaccine are warranted, given recent population coverage estimates of 71%–79% (influenza vaccine)5,7,11 and 51%–53% (23vPPV).5,7,11 A study of opportunistic vaccination among 4772 elderly hospital inpatients11 revealed a zero in-hospital opportunistic vaccination rate, despite virtually all unvaccinated subjects having had multiple visits (an average of 12) to vaccine providers in the community or the same hospital in the year before admission. Furthermore, only 2% of the inpatients had had their 23vPPV or influenza vaccination status recorded during admission — an omission previously cited as the single most important factor impeding opportunistic vaccination.12 Providers clearly have competing priorities and are failing to fully implement vaccination policy. Given the difficulties inherent in relying on self-reported vaccination status or written records, a register would greatly improve ascertainment of vaccination status among elderly people and potentially contribute to delivery of more vaccinations. Influenza vaccine and 23vPPV for the elderly are just two examples. It is highly likely that a national vaccination register would also improve the delivery and assessment of other vaccines received after age 7. An expanded register with the facility to include current and new National Immunisation Program vaccines beyond the 0–7-year age group could improve vaccination status and prevent over-vaccination. It would also allow evaluation of programs and monitoring of adverse events, and would be a valuable addition to any future national data linkage system that included health care records and drug prescription data, for which Australia has the potential to be a world leader.13 How Australia chooses to record vaccination status for all of its citizens will require careful consideration of costs and will no doubt be examined by the current scoping exercise. Assessment of the issue should include the potential human costs of incomplete vaccination and suboptimal monitoring of adverse events related to vaccination.

Susan A Skull FAFPHM, FRACP, MAppEpid · Terence M Nolan FAFPHM, FRACP, PhD

Financial motivation can encourage greater sports injury prevention efforts A landmark study published recently in the BMJ has shown that the rate of catastrophic spinal injury in rugby union in New Zealand has halved.1 For the period 2001–2005, the rate was 1.3 spinal injuries per 100 000 players per year, compared with 2.7 per 100 000 players per year in the period 1996–2000, which was typical of the previous 25 years.1 This drop coincided with the introduction of “RugbySmart” (http://www.rugbysmart.co.nz), a 10-point annual injury prevention program that was made compulsory from 2001 for all coaches and referees in New Zealand.1,2 While the observational study does not claim that the drop in catastrophic spinal injuries can be unequivocally attributed to RugbySmart, an accompanying editorial in the BMJ stated: “The beauty of the RugbySmart programme is that it can do no harm, and according to the results of this study may do great good”.3 What is the current state of play with respect to catastrophic spinal injuries in rugby in Australia? Although comparisons of spinal injury rates between New Zealand and Australia are difficult,1 recently published rates in Australia are substantially higher (between 3.24 and 6.85 injuries per 100 000 players per year). New Zealand is in a much better position to accurately determine incidence rates because compensation for all injuries (both sporting and from other causes) is available through a universal, government-funded scheme operated by the Accident Compensation Corporation (ACC).6 From 2005, the Australian Rugby Union (ARU) instituted a similar (but less extensive) program called “SmartRugby” for its referees and coaches. Tests of its effectiveness have not been reported, but it should be noted that the ARU does not have nearly the same financial motivation as the ACC to make it successful. In New Zealand, the ACC compensates for all catastrophic spinal injuries with lifetime medical care and annual replacement of 80% of wages, which can be up to NZ$14 million per case.2 In Australia in 2005, the maximum compensation paid to a rugby player rendered quadriplegic was A$300 000, accurately described by Carmody et al as “grossly inadequate”.4 This is particularly so when compared with a median payout of A$7.6 million for quadriplegia in recent negligence cases in Australia.7 Orchard and Finch argued in 2002 that, from a public health viewpoint, New Zealand’s system of maintaining a government body that monitors, compensates and seeks to prevent sports injuries is superior to Australia’s lack of any comparable system.6 Noakes and Draper suggested that New Zealand’s drop in spinal injuries “would not have been possible if the New Zealand government did not provide a national insurance policy that also covers sports injuries”.3 The ACC can also claim other successes in preventing sports injuries that we have not yet achieved in Australia. Mouthguard use in rugby in New Zealand has increased from 67% to 93%, reducing rugby-related dental claims to the ACC by 43%.8 A similar analogy can be used — in Australia there is no organised body paying dental claims, so there is no strong financial motivation to encourage increased mouthguard usage. The ACC is already in the position where it is evaluating New Zealand’s national sports injury prevention programs (in many sports) for cost-effectiveness, in terms of reducing injuries and claim payments.9 By comparison, in Australia there is generally no monitoring of sports injury rates, let alone well coordinated national sports injury prevention programs in place. If a national body was created in Australia to take on this role, even if it was not fully funded out of general revenue like the ACC, at the very least it could insist that federal government funding for sports be tied to minimum standards of monitoring injury rates and instituting injury prevention programs. Reducing work-related and traffic accidents have been listed as two of the top 10 public health achievements of the 20th century.10 These achievements would not have been possible without major bodies having responsibility for monitoring injury rates and instituting preventive measures. New Zealand is already showing that this model works equally well for sports injuries, so why should it not be applied in Australia? A new federal government body would cost money to establish and maintain, but the New Zealand experience suggests that subsequent savings may soon cover the costs of establishment and operation.2 In conclusion, the following matters deserve our urgent attention in Australia: The creation of a federal government body either primarily responsible for monitoring and preventing sports injuries or, at the very least, delegating these responsibilities to sporting bodies in a coordinated fashion. This body should compensate for injury, either (1) totally, as is the case in New Zealand; or (2) partially, in conjunction with sporting bodies, private insurers, public hospitals and Medicare. The minimum compensation for complete quadriplegia occurring in sport in Australia should be increased at least tenfold, both (1) to bring compensation for sporting quadriplegia more into line with compensation for quadriplegia arising from other causes; and (2) to give compensating and sporting bodies a much stronger financial motivation for prevention, as is the case in New Zealand.

John W Orchard MD, PhD, FACSP · Stephen R Leeder PhD, FRACP, FAFPHM · Gary E Moorhead BA(Hons), MEd · Jessica J Coates LLB(Hons), BEc · Peter D Brukner MB BS, FACSP

New technologies are often widely available to drivers before their safety can be evaluated In recent years, the availability of technological devices that can potentially be used while driving has expanded rapidly. One device that has received particular attention due to concern about driver distraction is the mobile phone. In this issue of the Journal, Taylor et al report on the use of handheld mobile phones by drivers in metropolitan Melbourne (→ Handheld mobile telephone use among Melbourne drivers).1 This observational study, which follows up research conducted by the same investigators in 2002, indicates that drivers continued to use handheld phones 4 years later, despite legislative and enforcement practices that prohibit their use and evidence that such use increases the risk of having a crash. On the other hand, the rate of use has remained steady even though mobile phone ownership has increased. Mobile phones are just one of a number of devices that may distract a driver. These technologies may be driving-related (eg, satellite navigation and intelligent speed adaptation [ISA] systems), or non-driving-related (eg, iPods, personal digital assistants and wireless email). Driving-related technologies seek to enhance drivers’ mobility and/or safety while non-driving related technologies do not. However, if poorly designed or used inappropriately, both types of technologies have the potential to compromise road safety. Aside from distraction, safety issues include: poor understanding of system operation; negative behavioural adaptation (drivers potentially taking more risks because their cars are fitted with additional safety equipment); system misuse; and increased driver workload. Thus, research is required to evaluate the safety implications of any device that can be used while driving. Apart from mobile phones, little is known about the proportion of Australian drivers who use driving-related and non-driving-related technologies and how frequently the technologies are used while driving. One survey conducted in late 2003 found that use of personal organisers and email was very low (0.3%) during a specified driving trip,2 but did not collect information on the availability and use of novel driving-related technologies. How the use of non-driving-related technologies affects driving performance is under investigation. To date, most research has involved the use of driving simulators. Studies have examined the use of mobile phones, stereo equipment and speech-based email systems, and have shown driving impairment.3-5 Epidemiological studies of the risk of crash relating to the use of devices other than mobile phones are currently lacking. Indeed, the rapid change in non-driving-related technologies means that road safety research can lag behind uptake of these devices by the driving public. In relation to driving-related technologies, early research is showing promise in enhancing safety, though much work remains to be done. A large field trial of ISA systems in Sweden involving over 10 000 drivers using about 5000 fitted vehicles demonstrated reductions in the mean speeds travelled.6 In Australia, the Transport Accident Commission (TAC) SafeCar project, which evaluated four driving-related technologies (ISA, following distance warning [FDW], seatbelt reminder [SR], and reverse collision warning) among 15 drivers using specially equipped vehicles, found positive effects for the ISA, FDW and SR systems.7 Recently, a naturalistic driving method has been developed in which drivers are videorecorded during their everyday driving.8 Multiple views are taken, including the driver, console, and the vehicle’s forward, rear and lateral views. The data can then be used to quantify drivers’ exposure to and interaction with technological devices while driving, and to estimate the risk (or benefit) associated with the use of these technologies. In addition to current research, a large naturalistic driving study to evaluate the safety of technological devices used in vehicles should be conducted in Australia. This will provide locally relevant data to inform the design of these technologies. Periodic surveys to monitor trends in the use of technological devices while driving are also indicated. The impact of driver distraction in all its forms (technological and non-technological) is considerable. Australian studies have shown that drivers commonly engage in distracting activities while driving, and that distraction is a contributing factor in 14%–21% of crashes;2,9 these figures are even higher among inexperienced drivers. In response, passenger restrictions and a ban on all mobile phone use (including hands-free) were introduced for novice drivers in New South Wales and Queensland in July 2007 as part of their graduated driver licensing systems. In Victoria, the TAC has recently launched a driver distraction media campaign to raise awareness,10 and a complete ban on mobile phone use while driving for novice drivers will be enacted in July 2008. Considerable gains have been made in the area of road safety in Australia in the past 30 years. If we are to maintain and improve on these gains, then managing the risks and benefits of technologies that can be used while driving will be critical. If certain driving-related devices are found to benefit road safety, then their uptake should be facilitated. Means to achieve this include regulatory requirements to ensure that new vehicles are fitted with the technology, that drivers are educated about the correct use and benefits of the technology, and that the technology is installed in vehicle fleets. Conversely, any technologies found to be unsafe will require measures to limit their use while driving. Car manufacturers and portable device developers will need to consider the potential for design improvements or the use of appropriate warnings.

Suzanne P McEvoy FAFPHM, MAppEpid, PhD

Withdrawal of government funding may force the closure of this invaluable resource General practice remains the cornerstone of Australia’s health services. About 85% of the population sees a general practitioner at least once in any year.1 Last financial year, that amounted to 103 million general practice services, at a cost to Medicare of $4 billion.2 Over the past decade, the Bettering the Evaluation and Care of Health (BEACH) program has provided a unique insight into these clinical encounters between GPs and their patients. BEACH tells us about the patients that GPs see, the problems that are encountered, and the treatment provided. The BEACH program is a continuous national study of general practice activity in Australia. Indeed, it is the only such study in the world. To date, it includes details of 900 000 encounters between GPs and patients. Every year another 100 000 encounters from a random, ever-changing sample of 1000 GPs are added. The strength of the BEACH data lies first in its sheer sample size, and second in that it provides a reliable, continuous measure of changes in general practice since 1998. Since that time, there have been a number of important changes to Medicare and a raft of new programs and initiatives to help GPs better manage their patients. These include financial incentives to boost bulk-billing, reimbursement for services provided by practice nurses, practice and service incentive payments for the management of patients with asthma and diabetes and for the provision of immunisations and cervical cancer screening tests, and new Medicare items to encourage GPs to work with allied health professionals to provide coordinated care for patients with complex and chronic health problems. Other factors have also intervened in the relationship between GPs and their patients. The GP workforce is increasingly older, has a higher proportion of women, and is looking to work fewer hours.3 At the same time there’s a growing shortage of GPs, especially outside metropolitan areas.4 Their patients are also ageing and beset by chronic illnesses such as heart disease, diabetes, arthritis, depression, and chronic obstructive airway disease. Many struggle to afford the out-of-pocket costs associated with their care, which have grown by 50% over the past decade.5 The push is on to get GPs to encourage their patients to exercise more and smoke less, to prescribe fewer diagnostic tests and medications, to talk to their patients for longer, to enquire about their use of alternative and complementary therapies, and to inform them about the use of generic medicines. This pressure is coming from government,6 professional bodies,7 the National Prescribing Service,8 and patients themselves.9 The BEACH data can be mined for information about all these issues and many more. It provides the only independent source of data about doctors’ prescribing practices, including how many prescriptions are for medicines not listed on the Pharmaceutical Benefits Scheme (PBS). The Pharmaceutical Benefits Pricing Authority uses calculations from the BEACH data to estimate the average monthly treatment cost of each PBS-listed medicine and then adjusts the price that the government pays the manufacturer. All this work is done by a small group of workers at the Australian General Practice Statistics and Classification Centre, a collaborating unit of the University of Sydney and the Australian Institute of Health and Welfare. It is done on a miniscule budget, which in the current financial year amounts to just $1.3 million. Now the Centre is under threat of closure because the Australian Government will not commit to ongoing financial support. The government’s contribution is just 23% of the BEACH budget (the remainder comes from a variety of public and private sources), but without the certainty of these funds for the 2008–09 financial year and beyond, the Centre must make the decision in November to close up shop. The amount involved is insignificant in the grand scheme of health expenditure — $300 000 a year — a sum so small that it is not itemised in the Australian Government Department of Health and Ageing budget, but is paid from the departmental expenses budget. Medical groups and academics have expressed concern that policy should be made and evaluated based on appropriate data, but the Department of Health and Ageing has signalled that it is no longer in the business of general practice research.10 Those who care about health policy and its impact understand the consequences if BEACH ceases to exist. Yet this rich and informative history of general practice activity is at risk because the Australian Government, in its short-sightedness, cannot make the 4-year commitment of $1.5 million that will ensure its future. The loss of BEACH will be a national shame.

Lesley Russell BSc(Hons), BA, PhD · Stephen R Leeder MB BS, MD, PhD

Their value in modern medical education needs to be reaffirmed Arguably the greatest claim to fame of the renowned English surgeon John Hunter was not his outstanding contribution to anatomy and surgery but the remarkable collection that now forms the Hunterian Museum in London.1 Hunter’s collection is testimony to his passion for science and his aptitude for self-directed enquiry, independent study and life-long learning. These attributes are now cherished cornerstones of modern medical education. Yet it is the adoption of these educational principles in modern medical curricula that is contributing to the demise of the time-honoured medical museum. No doubt Hunter would be saddened and dismayed at the plight that has befallen some of our wonderful collections of pathology specimens, medical and surgical artefacts and memorabilia. Most of these collections, which are housed in medical schools and teaching hospitals, were for a long time the exclusive province of medical students. Unfortunately, these repositories of medical history and the manifestations of disease are increasingly neglected, closed or under threat of closure.2 There are many reasons for this turn of events, including dramatic changes in medical education and medical practice over the past few decades, as well as financial problems common to all health care delivery systems. Medical museums (which include museums of pathology, anatomy and nursing) are perceived to be expensive facilities that do not have a well defined role in modern medical education and training. This is particularly so in graduate-entry medical courses and highly integrated courses, where it is often hard to identify the anatomy and pathology components of the curriculum sufficiently distinctly to be able to link them to museum-related study activities. Increasingly, medical students are sent to rural hospitals and practices remote from the central medical school (and museum) to gain clinical experience and encourage rural practice. In these environments, there is little opportunity to actually see “diseased tissue” as displayed in museums, or to pursue museum-related study activities. Reduced funding for medical education in a number of countries, including Australia,3 has diminished the survival prospects of medical museums. Additionally, the acquisition of new specimens, particularly specimens of human disease, has become a major problem. This is in part due to major advances in surgical techniques and the striking decline in the number of autopsies,4 so that acquisition of pathology specimens suitable for presentation and display has become near impossible. This has occurred in parallel with changes in the pattern of disease in developed societies, which have had an impact on the acquisition of specimens of infectious diseases (eg, tuberculosis, osteomyelitis and meningitis). Surgical specimens and donated bodies for anatomy dissection have been used by some medical schools to overcome the shortage of appropriate disease specimens. Unfortunately, changes to legislation on human tissue in various countries have made it so onerous and time-consuming to comply with the legislation that many pathology laboratories avoid retaining tissue.5 With the diminution in the museum’s traditional role in teaching medical students, museums that have survived and thrived have had to reinvent themselves. For example, the Museum of Human Disease at the University of New South Wales (UNSW), Sydney, has diversified its activities and no longer just provides specimens for use in tutorials and practical classes. Satellite museums have been established at the major teaching hospitals, so that students on secondment to remote teaching hospitals still have access to pathology specimens for study and for use in examinations. The museum at UNSW and several other university museums have also made their collections available online and/or in compact disk format. Students can now have the option of either visiting the museum or accessing its collection of specimens via the Internet. Several museums, such as those at the University of Western Australia, the University of Melbourne and UNSW, also have community education programs for high-school students and other interest groups. These have been enormously popular. For example, the Museum of Human Disease at UNSW now receives over 20 000 visits each year from high-school students. This has not only lifted the public profile of these museums and their medical schools, but has also provided additional funds to help support other museum activities. To survive in the increasingly difficult environment of medical education, it is important that museums become integrated into the new medical curricula. The value of pathology museums as a teaching resource should be recognised and emphasised. This is a particularly important issue, because some people see museums as a relic of the past that is dispensable. How can we promote the survival of these museums? Medical practitioners can help by supporting and promoting medical museums, as well as by doing volunteer work for, donating to and attending these wonderful repositories of our history. All those involved in medical education should stress the value of careful observation of disease and disease processes, on display in our museums, as a core learning activity. Fostering the public’s interest in disease by making medical museums more accessible will also contribute to the survival of this threatened species. Students and volunteers in the Museum of Human Disease, University of New South Wales.

Denis Wakefield MD, FRACP, FRCPA

Empathy should be sought and supported as a desirable, career-long trait in doctors Many observers have argued that medical practice is increasingly dehumanised, dominated by impersonal technologies and economic imperatives.1 A solution that is sometimes offered is to cultivate empathy in doctors.2 Many doctors may be sceptical, wondering whether empathy is too ill-defined to make a difference in the pressured arena of clinical work. Perhaps it can be safely left to essay-writing medical humanists or to the nursing staff . . . Such scepticism is unwarranted. Empathy can be defined as the capacity to take the perspectives of others, to be sensitive to their inner experience and to engage with them compassionately, rather than simply sharing their emotions (sympathy). In the medical context, empathy can be defined as “appreciation of the patient’s emotions and expression of that awareness to the patient”.3 More importantly, an emerging body of research indicates that empathy is associated with a variety of positive clinical outcomes. Much of the evidence linking doctors’ empathy to patients’ outcomes is indirect. Large bodies of research show that positive outcomes are associated with the quality of the doctor–patient relationship and doctor–patient communication, and that empathy enhances both. Direct links between empathy and clinical outcomes have also been established. More empathic medical students received higher ratings of clinical competence and performed better on history-taking and standardised physical examinations.4,5 More empathic medical students and doctors received higher patient satisfaction ratings.5 Patients judge empathy to be very important in consultations,6 and show better treatment adherence and greater enablement with more empathic doctors.7 When doctors report a loss of empathy they subsequently show an increase in their rate of major medical errors.8 Doctors’ communication skills are associated with a variety of positive outcomes for patients9 and with reduced risk of malpractice claims, and patients judge their doctors’ empathy on the basis of such skills (eg, being reassuring, showing understanding, explaining procedures, not ignoring their concerns).10 If empathy promotes positive clinical outcomes, then we should want doctors to be empathic. This aim could be achieved by promoting empathy in medical training, and by using empathy as a selection criterion for entry to medical training. These two approaches reflect the reality that empathy is a disposition or quality, but also one that is malleable. Many ways of promoting empathy have been proposed, ranging from training in communication skills, to education in the medical humanities, through to complete overhaul of the medical curriculum. A review of intervention studies suggests that communication skills workshops have the greatest impact on medical students’ empathy.3 Assessing empathy as a criterion in medical school admission is more controversial, and there is as yet little direct evidence that it would produce better doctors. Nevertheless, several studies make an indirect case for supplementing traditional selection procedures, which are based heavily on educational attainment and cognitive ability, with measures of empathic traits. First, measures of empathy are generally unrelated to indices of attainment and ability, but capture non-redundant information that is relevant for selection. For example, one study found that empathy correlated highly with selection interview scores,11 but not with academic grades or a standardised aptitude test. Second, psychometric measures of empathy have been shown to predict real-world empathic behaviour, and should therefore be able to identify applicants who are especially likely to interact empathically with patients. Finally, including empathy assessment in the selection process is likely to increase access to medical training for less socially privileged applicants. Such students tend to fare less well on traditional criteria, but perform equally well or better on assessments of empathic traits.12 The possibility that broadened selection criteria might tend to favour female applicants, given evidence of sex differences,2 must also be entertained. Even if doctors’ empathy can be enhanced by medical education or selection, it is at least as important to prevent the erosion of empathy over the course of professional training and practice. There is now considerable evidence that levels of empathy tend to decline during medical school and beyond.13 This decline has been attributed to the growing reliance on technology, and to economic and time constraints imposed by health care systems. Others identify psychological dynamics beneath the loss of empathy, such as creeping cynicism, a self-protective disengagement from people’s suffering and a sense of hopelessness in the face of therapeutic failure. Research indicates that the loss of empathy is linked to burnout — notably, feelings of emotional fatigue and a tendency to depersonalise patients. Trainees who make major medical errors subsequently experience a decline in empathy.8 Similarly, doctors who feel less in control of patient outcomes tend to engage in styles of closed, impersonal and inattentive communication that lead patients to see them as unempathic.10 There is a positive side to all of this. Empathy can be lost, but it can also be gained. If doctors lose empathy because of burnout, unhappiness and a loss of a sense of control over their work, then remedying these conditions should indirectly increase empathy. Indeed, doctors who report higher levels of wellbeing and a greater sense of personal accomplishment also report higher levels of empathy,14 and increases in wellbeing among residents are accompanied by increases in empathy.15 If empathic doctors are indeed better doctors, then improving doctors’ wellbeing should benefit patients.

Nick Haslam PhD

Potentially serious metabolic sequelae make diagnosis and intervention imperatives Polycystic ovary syndrome (PCOS) is the most common endocrine abnormality of women of reproductive age. The diagnosis is based on the presence of two of three criteria — ovulatory disturbance, hyperandrogenism, and polycystic ovaries on ultrasound. However, in most women, insulin resistance is central to the pathogenesis of the syndrome, with hyperinsulinaemia driving both androgen production and androgen bioavailability as the key diagnostic feature.1-3 In PCOS, insulin resistance not only contributes to symptoms, but also has serious sequelae including infertility, impaired glucose tolerance, a fourfold to sevenfold increase in diabetes and a potentially increased risk of cardiovascular disease.3 PCOS affects an estimated 400 000 Australian women; this is 5%–10% of the reproductive age group. Obesity exacerbates insulin resistance and glucose intolerance in PCOS. As obesity in the community increases, the prevalence of the PCOS phenotype and its associated glucose intolerance — including diabetes — are expected to rise significantly. In 2006, the estimated economic burden of PCOS in the United States was $6 billion, equating to $400 million in health care costs in Australia (with menstrual dysfunction consuming 31%, infertility 12% and PCOS-associated diabetes 40% of total costs), representing a major health and economic burden.4 An economic evaluation of PCOS recently advocated screening, diagnosis and intervention, justifiable by ameliorating or preventing serious sequelae.4 However, greater understanding of appropriate screening, long-term risks and effective interventions is urgently needed. In this issue of the Journal, Dabadghao and colleagues report a retrospective study of a large cohort of Australian women with PCOS presenting to an infertility service, and tackle the important issues of abnormal glucose tolerance and metabolic syndrome in PCOS (→ Glucose tolerance abnormalities in Australian women with polycystic ovary syndrome).5 In the study by Dabadghao et al, most women with PCOS were obese, with a mean body mass index (BMI) in their cohort of 35 kg/m2. Impaired glucose tolerance was noted in 15.6% and diabetes in 4%.5 The key predictors of abnormalities in glucose tolerance were age, BMI, metabolic syndrome and a family history of diabetes.5 Previous reports on the prevalence of metabolic complications of PCOS have shown inconsistent results, related to the diversity of populations studied (age, BMI, ethnicity) and the different diagnostic criteria applied for PCOS and for impaired glucose tolerance and diabetes. The study by Dabadghao et al used the current Rotterdam criteria for diagnosing PCOS and the World Health Organization criteria for impaired glucose tolerance and diabetes. While the ethnicity of the population is not described in the Dabadghao et al study, and the population is selected (all women had attended a fertility service), their findings in this large cohort highlight the high prevalence of metabolic complications in women with PCOS in Australia. PCOS is a heterogeneous condition, and there are undoubtedly varied genetic and environmental influences on its development and expression, with challenging clinical and research questions still to be answered. However, given the aetiological and exacerbating roles of obesity and insulin resistance in most women with PCOS, it is imperative that clinicians are aware of the metabolic implications of this syndrome. Screening for metabolic complications, as recommended by Dabadghao et al, needs to include a 75 g 2-hour oral glucose tolerance test and lipid profile determination at diagnosis, and regularly over time.5,6 Frequency of screening should be based on the key predictors for development of diabetes (as noted by Dabadghao et al) — age, BMI and family history of diabetes.5 It should be noted that measuring insulin levels does not have a clinical role in screening or in guiding management and remains a research tool. Prevention and treatment strategies should also be more aggressively pursued in these higher risk subgroups. Lifestyle modifications are first-line interventions in the treatment of insulin-resistance states (obesity, PCOS, prediabetes and diabetes). In PCOS, improvements in insulin resistance, ovulation, androgen levels and fertility have been shown with as little as a 4%–5% drop in bodyweight achieved with caloric restriction (independent of dietary composition), with or without exercise programs.7,8 In populations not affected by PCOS, lifestyle changes as well as insulin sensitisers (including metformin) significantly delay the onset of diabetes in those with impaired glucose tolerance;9 similar delay is likely with such changes in patients with PCOS. Lifestyle therapy should be realistic (initial goal of about 5% weight loss), feasible, achieved through sustainable lifestyle change rather than short-term caloric restriction, and supported by a multidisciplinary approach.7,8 In combination with lifestyle change, insulin sensitisers are likely to have a role in those at highest risk, especially where impaired fasting glucose or impaired glucose tolerance is already established.10-12 It is now recognised that PCOS is not simply a reproductive condition characterised by the appearance of the ovary on ultrasound, but represents a complex interplay between insulin metabolism and androgen production. The high prevalence of abnormalities of glucose metabolism and of the metabolic syndrome in women with PCOS mandates a proactive approach to screening and prevention. A recent survey of Australian clinicians treating women with PCOS found that screening for metabolic complications of PCOS has not been as widely practised as is advocated and supported by the literature in general,13 including the study by Dabadghao et al. A change to more proactive screening and intervention is likely to reduce the burden of disease associated with PCOS.

Helena J Teede FRACP, PhD · Bronwyn G A Stuckey BA, FRACP

Combining clinical diagnostic scoring with D-dimer analysis Venous thromboembolism (VTE) occurs in one to two people per 1000 annually in Caucasian populations.1 About a third of these patients will have symptomatic pulmonary embolism (PE), which is associated with a mortality rate of about 30% if left untreated.2 Anticoagulant therapy is highly effective for preventing death in patients with symptomatic PE,3 but causes major bleeding in 2% of patients during the first 3 months. The mortality rate among patients who suffer major bleeding is about 10%.4 Accurate diagnosis is thus critical to ensure that patients with PE receive effective treatment and that patients without PE do not receive unnecessary anticoagulant therapy, with its associated risks and inconvenience. The diagnosis of PE is challenging because of the wide spectrum of symptoms and signs, and because most patients with suggestive clinical features do not have the disease.5,6 Major risk factors for PE include trauma, surgery, and a diagnosis of cancer, but half of patients with symptomatic PE do not have an identifiable risk factor.1 Typical symptoms of PE include dyspnoea or acute chest pain and, less commonly, cough or haemoptysis, while typical signs include tachycardia, tachypnoea and, less commonly, right ventricular dysfunction.5 However, none of the typical clinical symptoms and signs are unique to the disorder or invariably present in patients with confirmed PE. Thus, the clinical diagnosis of PE is unreliable and additional testing is required to confirm or refute the diagnosis. The accuracy of non-invasive testing, which has almost completely replaced pulmonary angiography in the diagnosis of PE, is substantially improved when combined with an assessment of clinical pre-test probability and the results of a sensitive D-dimer assay.5 Experienced clinicians can use clinical judgment (“gestalt”) to assign a pre-test probability of PE with reasonable accuracy, but simple clinical prediction rules, such as the one developed by Wells and colleagues,7 perform equally well and can be used by less experienced clinicians.5 To date, the Wells model has not been evaluated in an Australian setting. In this issue of the Journal, Yap and colleagues report the results of a prospective cohort study in which they evaluated the use of Wells’ model in 633 consecutive inpatients and outpatients with suspected PE referred for lung scanning at a major Australian teaching hospital (→ A prospective reassessment of the utility of the Wells score in identifying pulmonary embolism).8 Lung scans and multidetector computed tomography (MDCT) were used as the reference standard to establish the diagnosis of PE (positive lung scan or positive MDCT) or to exclude PE (negative lung scan or non-diagnostic scan with negative MDCT). They found that a low clinical pre-test probability of PE (Wells score < 2) was associated with a 4.3% prevalence of PE; a moderate clinical pre-test probability of PE (Wells score 2–6) was associated with a 13% prevalence of PE; and a high clinical pre-test probability of PE (Wells score > 6) was associated with a 67% prevalence of PE. There was no follow-up of patients once diagnostic imaging was completed, and PE may have remained undiagnosed in some patients. Nonetheless, the prevalence of PE in the low, moderate and high pre-test probability categories reported by Yap and colleagues is almost identical to the prevalence reported in the original study by Wells and colleagues,7 and confirms the ability of the Wells score to accurately classify patients according to their clinical pre-test probability of PE. Some investigators9,10 have suggested that patients with a low pre-test probability of PE do not require further investigation because the prevalence of disease in this group is low. However, the risk of missing a diagnosis of PE in such patients can be further minimised by combining the clinical assessment of pre-test probability with the results of a D-dimer assay. Depending on the sensitivity of the D-dimer assay, patients with low or moderate pre-test probability for PE may not require diagnostic imaging if they have a negative D-dimer test. Patients with a low pre-test probability and a negative moderately sensitive D-dimer assay, or patients with a low or moderate pre-test probability and a negative highly sensitive D-dimer assay do not require diagnostic imaging because the prevalence of disease in these patients is very low (less than 2%).11 By contrast, patients with a positive D-dimer test and/or those with a high pre-test probability require diagnostic imaging. For the past 20 years, clinicians have used lung scanning as the first-line non-invasive imaging test for patients with suspected PE. A normal or near-normal lung scan reliably excludes PE, while a high-probability lung scan confirms the diagnosis. However, as many as half of patients with suspected PE have a non-diagnostic lung scan result, and a quarter of these have PE.12 Newer lung scanning techniques may reduce the proportion of non-diagnostic scans, although the number of non-diagnostic scans reported by Yap and colleagues is unexpectedly low. MDCT is more rapid and convenient than lung scanning, but requires intravenous injection of contrast medium that is potentially nephrotoxic. The test can also yield non-diagnostic results.13 Clinicians must interpret non-diagnostic results of imaging studies in the context of the clinical pre-test probability of PE: patients with a moderate or high pre-test probability of PE and a non-diagnostic scan generally require additional or serial testing to establish or refute the diagnosis.12,13 Patients for whom there is a marked discrepancy between the pre-test probability of PE and the results of diagnostic imaging should also undergo further testing.13 The outcomes for patients with suspected PE can be improved by routine use of written diagnostic algorithms that incorporate a clinical probability scoring system.14 Yap and colleagues have validated the Wells probability scoring system in the Australian setting, and their data should encourage efforts by clinicians and institutions to implement standardised diagnostic strategies that combine assessment of clinical probability with measurement of a sensitive D-dimer in all patients with suspected PE.

Simon J McRae MB BS, FRACP, FRCPA · John W Eikelboom MB BS, MSc, FRACP

Significant similarities between the challenges of lung transplantation in patients of all ages should lead to better access to this life-saving surgery for children and adolescents Lung transplantation (LTx) is firmly established as a therapy for end-stage lung and pulmonary vascular diseases in patients aged over 18 years and into the seventh decade of life.1,2 However, for those under the age of 18, be they child or adolescent, the role of LTx is less clear.3,4 In Australia, this has contributed to a perception that the risk of undertaking LTx in children and adolescents does not warrant the reward. Indeed, presently in this country, there is no major paediatric hospital offering a lung transplant program, likely recognising the complexity of treating such patients coupled with the potential risk of achieving poor results with a low case load — the reality is that the projected case numbers will only be of the order of four to eight per year across Australia and New Zealand. Thus, by focusing on successful LTx outcomes for an adolescent population, the article by Morton and colleagues in this issue of the Journal5 highlights a number of the key issues regarding the efficacy and utility of LTx for younger Australians (→ Successful lung transplantation for adolescents at a hospital for adults). Although adolescence refers to a transitional state from childhood to adulthood, patients 15 years and younger are generally excluded from adult hospitals and those 18 years and above excluded from paediatric hospitals. Two-thirds of the patients in the study by Morton et al could have been “routinely” treated in adult hospitals. Notwithstanding this limitation, the report gives important insight into the issues, experience and successful outcomes that can be achieved in younger lung transplant recipients. From this article, it is apparent that in Australia, a well developed, large adult LTx unit is able to use its highly specialised services to overcome some of the problems and deficiencies that can limit a stand-alone service for such a small population as children and adolescents requiring LTx. However, the age of any potential Australian lung transplant recipient is critically important — at this time, this technology is not being routinely offered to younger children. Indeed, at present, Australia’s youngest ever lung transplant recipient was aged 9 years at the time of LTx.6 The improved outcomes for LTx now described in adolescents5 should provide an impetus to provide access for younger potential LTx recipients. In looking to achieve this advance, we need to keep in mind that the transplant recipient’s age can matter in several different ways. Fortunately, severe lung disease warranting consideration of LTx in children and adolescents is relatively rare, although interestingly, it does have a bimodal distribution. The International Society for Heart and Lung Transplant (ISHLT) Registry 2005 paediatric report notes about 65 procedures performed worldwide each year.7 In older paediatric patients, typically over 12 years of age, about 70% will have cystic fibrosis as the primary indication for LTx, whereas in infants aged less than 3 years, the indication in about 60% is congenital heart disease or pulmonary hypertension. Despite the perception that transplant recipients fare worse if they are younger, the recent ISHLT Registry reports a half-life of around 5 years after LTx, and no significant survival difference between adults, adolescents and the very young.7 Rates of early graft dysfunction and late graft dysfunction (ie, bronchiolitis obliterans syndrome [BOS]) are also similar. However, causes of death are quite different, with adults and adolescents dying from respiratory failure related to BOS, and younger children dying from infection. The functional status of survivors is excellent, with over 80% reporting no activity limitations at 5 years,7 although morbidity related to the obligatory immunosuppressant drugs is very common across all age groups. Further, there are some specific issues (medical, psychosocial and legal) associated with LTx in adolescents and children compared with adults. Post-transplant lymphoproliferative disorders, growth retardation, respiratory tract infections and medical non-adherence appear much more commonly in children.8 As discussed by Morton and colleagues, facilitating compliance with therapies and medication are particularly challenging areas when working with adolescents.5 As an example, immunosuppressive protocols need to reflect potential concerns about physical appearance. Also, a particular “at risk” period arises when paediatric LTx recipients transition from paediatric to adult care.9 Performing major surgery with substantial short-term and long-term mortality risks in a patient unable to give consent presents ethical and legal dilemmas. For paediatric patients with severe lung disease, recent technological advances provide the potential to build on the excellent results of LTx in adolescents presented by Morton et al.5 Minimal waiting list mortality is a critical component of any assessment of the efficacy and utility of organ transplantation. Thus, the management of severe lung disease by experienced teams, with appropriate use of newer therapies such as bi-level positive airway pressure (BiPAP), dornase alfa and azithromycin in patients with cystic fibrosis, may lead to a successful “bridge to transplant”. Similarly, intravenous epoprostenol, oral bosentan and sildenafil may provide a bridge to transplant for patients of all ages with severe pulmonary hypertension. The study by Morton et al included several terminally ill individuals transplanted after support with mechanical ventilation or extra-corporeal membrane oxygenation.5 Morton and colleagues are to be commended for their successful endeavour, but we contend that further detailed discussion about excessive early mortality10 and resource use is needed before bridging in this fashion is routine in any age group. Such bridging has become increasingly used in the United States (11% of all LTx in 200611) and we believe that many, including ourselves, would argue that Australia does not have the intensive care facilities and staff to routinely bridge in this manner. There are also other developments that should increase transplant opportunities and access to LTx for children and adolescents, hopefully shortening waiting times, thereby further decreasing waiting list mortality, and potentially allowing at least the possibility of retransplantation in the event of late graft dysfunction. One possibility is that large-volume LTx transplant centres (typically not small-volume paediatric-only centres, as yet) might increase organ availability by using extended donor lungs (eg, where there are secretions or an abnormal chest x-ray, etc),12 or cadaveric or living-related lobar transplants (eg, so-called “cut-down lungs”).13 The use of cut-down lungs typically involves transplanting one lobe from each of two adults to make a bilobar transplant for a child or smaller adolescent. Although this resource-intensive and challenging operation is possible, some question the philosophy of undertaking the only known procedure to have a “potential 300% mortality”.13 Donation-after-cardiac-death (DCD) retrieval of lungs for transplantation (as distinct from the usual donation-after-brain-death retrieval) is also now a viable prospect being used to acquire adult lungs for LTx,14 and will soon be extended to paediatric DCD lung donation.15 Thus, evidently, expanding the complexity and extent of LTx offered to children and adolescents might consume significant resources, so LTx results must be carefully considered and evaluated to ensure continued successful outcomes. In this regard, we note with great interest the recent institution of a complex mathematical lung allocation score model by the American United Network for Organ Sharing (UNOS).16 This model uses disease-relevant clinical and physiological variables to predict who will get the most significant improvement in survival with LTx and, therefore, who should be preferentially transplanted. Although historically based, the model will evolve with ongoing clinical experience and should be able to provide new evidence to guide future practice. Interestingly, because of differences in diagnostic categories and post-LTx outcomes in younger lung transplant recipients, the UNOS lung allocation score is only to be applied to those aged over 12 years.16 So, although there are important differences to consider when evaluating the efficacy and utility of LTx across the wide age-spectrum of disease and physiology in the very young, adolescents and adults with terminal lung disease, there is also significant overlap. Medical and allied health experts in paediatric and adolescent medicine have much to offer adult LTx programs venturing into adolescent transplantation; their involvement should be routine. Similarly, units experienced in adult LTx bring knowledge and technology to paediatric and adolescent LTx that can only benefit the small number of critically ill young Australians previously without local access to LTx expertise.

Gregory I Snell MB BS, FRACP, MD · Glen P Westall MB BS, FRACP · Trevor J Williams MB BS, FRACP, MD

Australia is well placed to again lead the world in health technology assessment Australia led the world in 1993 when it introduced the so-called “fourth hurdle” of economic evaluation into the approvals process for drugs (in addition to the usual regulatory “hurdles” of quality, safety, and efficacy).1 We are among the dozen or so developed countries that had invested in health technology assessment (HTA) since the early 1980s, but it was the requirement of a favourable economic evaluation that attracted international attention to HTA in Australia.2 While economic evaluation had always been considered a component of HTA, a policy requiring evidence of cost-effectiveness was groundbreaking.3 In 1998, the federal Minister for Health created a parallel HTA process for new medical services. Evidence of sufficient safety, effectiveness and cost-effectiveness to be included in the Medicare-subsidised benefits package now forms the basis for coverage recommendations to the Minister by the Pharmaceutical Benefits Advisory Committee (PBAC) for drugs, and the Medical Services Advisory Committee (MSAC) for medical services and technologies (Box).5 In contrast to most other countries, HTA in Australia has been woven into the fabric of health services funding, giving it greater impact on the introduction of new treatments. Our approach is similar to that of the United Kingdom’s National Institute for Health and Clinical Excellence6 but differs from Canada’s more “hands off” implementation approach,7 both described in this issue of the Journal ("Health technology assessment in England: assessment and appraisal" and "Health technology assessment in Canada: diversity and evolution", respectively). Most other countries have structured their HTA processes to be “advisory” to doctors and health care services. It is unclear whether this separation of advice from funding is more effective than the direct application of HTA to coverage decisions seen in Australia and the UK, but a common lament from academics and policy-makers in such systems is that HTA findings are not “taken up” by health care providers.8,9 Separating HTA from coverage decision making may lead to less contention with professional groups and the biotechnology industries, but perhaps also reduces the impact of the HTA effort. Because of their direct impact on government coverage decisions, and the still novel requirement for an acceptable incremental cost-effectiveness ratio, both the PBAC and MSAC have been subject to industry and political scrutiny. The most comprehensive inquiry was a 2005 Productivity Commission report on advances in medical technology in Australia.10 The PBAC was a major focus of negotiation leading to the Australia–United States Free Trade Agreement,11 and the MSAC has conducted an internal review and consultation process,12 in part as a response to industry criticism of delays in the assessment process.4 A third article in this issue of the Journal by Petherick and colleagues (→ An evaluation of methods used in health technology assessments produced for the Medical Services Advisory Committee) examines the evolution and shortcomings of systematic reviews in published MSAC assessment reports since 1998.13 Although the Australian system is apparently fragmented (medicines versus services, federal versus states, public versus private systems), differing characteristics of each may justify separate approaches. It is clear that the longer history of drug safety regulation makes pharmaceutical evaluation more straightforward than evaluation of medical services.10,14 Surgical interventions provide their own unique challenges to evaluation methods, and the Australian Government has funded ASERNIP-S (Australian Safety and Efficacy Register of New Interventional Procedures — Surgical) to conduct HTAs under the sponsorship of the Royal Australasian College of Surgeons.15 Funders at each level of the system (federal and state) have differing responsibilities and interests, probably best served by dedicated evaluation efforts, but there has been considerable synergy in the development of HTA among these stakeholders. The Productivity Commission report highlighted a number of recent developments that fill gaps and reduce friction between the needs of different HTA users.10 Through the Australian Health Ministers’ Advisory Committee (AHMAC), the states pool funds to sponsor HealthPACT (Health Policy Advisory Committee on Technology) which performs “horizon scanning” for state health departments,16 and shares secretariat and other functions with MSAC. This mechanism alerts the funders of public hospitals to emerging medical technologies with potential to influence their health care systems. The states together determine HealthPACT’s budget and work program. In addition, AHMAC has delegated to MSAC a role in advising on Nationally Funded Centres (NFC). These are services where the volume of relevant cases is not sufficient to justify more than one or two units in the country — historically, these have been transplant units. The NFC designation ensures that all states contribute to funding of such units, thus guaranteeing access for residents of all states. State health departments are developing their own HTA capabilities. For example, the Victorian Policy Advisory Committee on Clinical Practice and Technology17 was set up in 2004 to undertake a variety of HTA activities, including horizon scanning, assessment and monitoring for the Victorian Department of Human Services. State-based committees commonly consider applications for high-price and/or high-volume drugs, devices and procedures, and create a mechanism to approve funding for novel or statewide specialty services outside normal hospital funding arrangements. Hospitals and regional health services in Queensland, Western Australia, South Australia and Victoria have established internal HTA committees to oversee the introduction of new drugs and medical procedures, with examples from Bayside Health and Southern Health in Victoria cited by the Productivity Commission in its report.10 Public hospitals, with their role in medical education and research, may need to focus on different technologies at different stages of the product development cycle than do private hospitals and health insurers. In contrast to Australia, the HTA efforts of Canada and the UK have a unified approach to drugs and other technologies. The UK National Institute for Health and Clinical Excellence has an advantage over MSAC and PBAC in setting its own agenda, the so-called “needs-led” prioritisation of HTA topics. Canadian HTA organisations seem to balance the needs of the system as a whole against those of particular interests, including those of funders,7 but probably come closer to HealthPACT’s user-led prioritisation. All jurisdictions grapple with the politically charged problem of “disinvestment” — that is, ceasing to support therapies whose effectiveness (and/or cost-effectiveness) cannot be demonstrated. Both the UK and Canada have successfully pioneered “rapid response” methods for HTA users requiring timely answers to tightly framed clinical questions, an approach not yet common in Australia. Clinical evidence for HTA is derived from systematic reviews, and these in turn rely on randomised controlled trials (RCTs). Evidence-based medicine has refined the tools available for evaluating evidence of clinical benefit; basic physiological evidence of efficacy can come from trials in any country. However, evidence of real-world effectiveness is dependent on the medical culture, workforce and referral patterns of a particular health system, and economic evaluation is even more dependent on the organisational forms of health care, including the skills mix and relative wages of different professional groups. Generally economic assessments use decision–analytic models, with key outcomes costed locally to determine the cost-effectiveness of an intervention in each health care system. None of the national HTA processes described has the capacity to commission new clinical research, and there is little articulation with existing medical research priority-setting processes. This often results in rejecting new technologies because there is no RCT evidence of their efficacy or effectiveness, rather than evidence that they are ineffective.4 Both the UK and the US are trialling “coverage with evidence” approaches to funding new medical technologies as a way of bridging current gaps in evidence.18 These allow introduction of new services or biotechnologies on the condition that patients are entered into rigorous clinical trials, and with the understanding that continued funding will depend on the evidence from these trials. The coming of molecular medicine with its individualised and gene-based therapies will exacerbate the lack of clinical evidence from RCTs.19 The “demise of the blockbuster” drug will demand a new research-intensive paradigm for evaluation and regulation of therapies in developed countries.20 Monitoring drug safety21 and funding the collection of randomised evidence22 are possible in Australia, even with current evaluation tools. However, we will need focused effort to develop more “fine-grained” clinical epidemiology techniques to identify patient characteristics that mediate response to treatment and define which subgroups are likely to derive how much benefit from new treatments at what cost. The phrase “rapid learning health system” has recently been coined to characterise the ways in which computerised medical information can be used to inform health care decision making from the bedside to national HTA efforts.23 With Australia’s large health information technology investment, well established disease registries and systematic metadata specifications, we are in a position to pioneer rapid learning strategies that can be used earlier in the evaluation process, and at an acceptable research cost. The challenges then are to manage the inevitable tensions that arise when HTA directly influences funding decisions, to tailor HTA methods to the needs of different stakeholders with differing timelines, to focus HTA strategically to meet national needs including the capacity to disinvest from ineffective treatments, and to supplement RCT efficacy evidence with real-world evidence of effectiveness and cost-effectiveness. Australia could once again claim leadership of international HTA by creating the evaluative and funding mechanisms to rise to these challenges. Requirements for Medicare subsidy of drugs and medical technologies in the Australian health care system Drugs Applicants are required to prepare detailed evidence-based submissions to the Pharmaceutical Benefits Advisory Committee (PBAC), once drug safety has been assessed by the Therapeutic Goods Administration (TGA). Applications are rigorously assessed by health technology assessment (HTA) organisations contracted to PBAC, which then provide confidential reports to PBAC. All documentation for PBAC recommendations is considered “commercial in confidence”, and only brief reports on decisions and deferrals are published. Medical services and technologies The Medical Services Advisory Committee (MSAC) undertakes its own assessments, also by contracted HTA organisations. MSAC reports are published once the Minister has made a determination about listing on the Medical Benefits Schedule. About a third of the work program of MSAC comes as referrals from the federal Department of Health and Ageing.4

Terri J Jackson PhD

A chance to make real gains in eliminating child abuse and the health, social, and economic problems associated with it The vigorous involvement of the Australian Government in addressing issues of child abuse in Aboriginal communities in the Northern Territory has been widely welcomed. The discussion that followed the Howard Government’s announcement (Box 1)1 has not been about whether there is a need to act — some of these interventions, in particular increased policing and better health services, have been called for by these NT communities for many years — but there has been debate about the way in which action should be taken. The intervention is attempting to confront a real and acute problem of child sexual abuse, using a legalistic and “tough love” policy approach. However, as well as an urgent response, sustainable solutions are needed to deal with the broader health and social issues that underpin child abuse, and it is important that these articulate with the longer-term aspirations of Aboriginal and Torres Strait Islander peoples and communities. These aspirations are much more comprehensive than a law and order approach delivering an “absence of fear”. A complex set of factors are associated with the occurrence of child abuse. A review of child abuse in the United States found poverty to be the most frequently and consistently noted risk factor.2 Community-related risk factors included a high crime rate, lack of social services, and a high unemployment rate. Parental-related factors included a history of physical or sexual abuse, being teenage or single parents, poor coping skills, low self-esteem, substance misuse, lack of parenting skills, mental health problems, and having multiple young children. Although there is far from an exact parallel between the situation in the US and that in the NT, there are some factors in common. Strategies recommended for preventing child abuse in the US included: increasing economic self-sufficiency; discouraging all forms of violence against children, including corporal punishment; making health care more accessible; expanding and improving the coordination of social services; improving treatment for psychological problems, and for substance misuse and spouse abuse; providing affordable child care; and educating parents about child behaviour, discipline, safety and development.2 The recent report from the Australian Productivity Commission entitled Overcoming Indigenous disadvantage3 provides contemporary information on many of these risk factors in the Aboriginal population. The report shows that rates of substantiated notifications of child abuse have increased. However, unemployment rates are down, there is more home ownership, basic education levels are improving, and there have been increases in native title determinations. While some aspects of child health are improving (although there is still a considerable way to go), a lack of progress or even deterioration in some health indicators point to continuing inadequacies in health services for Indigenous Australians. The problem of overcrowding in houses has not been solved, and risky alcohol consumption has not abated for men and has increased for women. Imprisonment rates for adults have increased, and the gap between Indigenous and non-Indigenous juvenile detention rates has widened. In announcing the measures that the government would take to deal with child sexual abuse, the Prime Minister drew attention to the comprehensive report into child sexual abuse in the NT by Pat Anderson and Rex Wild entitled Little children are sacred. However, the government’s response, at least as regards the initial strategies, has been in direct contrast to the recommendations of this report,4 in both content and philosophy.5 The government measures involve considerable reliance on uniformed services and coercive interventions, and limited consultation with the Aboriginal communities and leaders concerned. Evidence for the effectiveness of some of the Howard Government’s strategies does not appear to exist; nor does this seem to have been a dominant consideration. The relationship of land tenure to child sexual abuse is very poorly defined in the intervention, and detailed clarification of this aspect by the government would help to instil some trust in this aspect of the government’s response in the relevant communities. The same applies to the removal of the permit system: the need for permits would logically appear to be a deterrent to predators entering Aboriginal communities. Finally, it is not clear whether alcohol prohibition really works in the long-term. No one would say it was a spectacular success in the US or Russia, and in Indigenous communities in the Cape York Peninsula and in Canadian Indigenous communities the results of this measure have been mixed. In Native American communities in the US, it has been counterproductive,6 but it has provided some benefits in the particular circumstances of Alaska.6 A majority of remote NT Aboriginal communities are already “dry” by choice, and any such action should be negotiated with individual communities, and must include planning for the withdrawal of alcohol, as well as counselling. On the positive side, the government’s intervention will focus much more attention on the issues associated with child abuse, and give voice and opportunity to attempts to say much louder that the unacceptable really is unacceptable. So, at least, some short-term gains may be made, and there is some prospect of a residual shift in attitudes to child abuse and domestic violence. More importantly, the intervention engages the government and a committed Minister in efforts to tackle these vitally important issues. Nevertheless, the abuse of children cannot be dealt with effectively as a separate issue without also addressing the related health, social, education, and economic issues — and it will not occur without the full engagement of Aboriginal communities. Attempts to confront this emergency will immediately come up against longstanding problems, not just of the welfare system and exposure to alcohol and pornography, but of environmental and housing issues; and deficiencies in mental and other health services, in the law enforcement system, and in social services; and, finally, the manifest weaknesses of the criminal justice system. There are also problems related to workforce, training and accommodation for staff working in Aboriginal communities. Most importantly, there is the lack of self-esteem, the need for cultural strengthening, and the paucity of meaningful activities for individuals and communities. The record of those initiatives in Australia, no matter how well intentioned, which have been largely driven by the non-Indigenous community and lacked full Indigenous partnership, is pretty bleak. Disempowerment of Aboriginal people is a significant factor in the complex set of problems, and measures that lead to further disempowerment have, at best, doubtful prospects. We urge that, at the earliest possible stage, the government consider enlisting the support and involvement of Indigenous leaders in the health field, and give much more serious consideration to the community-engagement strategies and the more comprehensive approach outlined in the Anderson Wild report (Box 2).4 Child sexual abuse is not restricted to the NT, and the proper vehicle for addressing this issue at a national level is the Council of Australian Governments. The starting point ought to include those strategies that have been found to be effective in dealing with the abuse of children in Australia and other countries. Intervention trials, such as the initiative led by Noel Pearson in the communities of the Cape York Peninsula, should provide valuable information. The solution lies in taking action with Aboriginal people and communities rather than for them. With the Prime Minister’s promise7 that whatever resources are needed will be provided by the federal government, there is a tremendous opportunity for innovation, as well as effective implementation of the many strategies that have appeared in numerous government reports over many years in both health and other fields. It is a chance to make real gains in eliminating child abuse and the health, social, economic and other problems that are associated with it, but this requires bipartisan commitment for sustained, long-term interventions. The worst that could happen is that these communities are promised real, positive changes and the promise is again not fulfilled. We must do whatever it takes to save these children from sexual abuse today, but we must also ensure safe, healthy communities and a meaningful life for the children born into these communities in the years to come. 1 Measures announced by the Australian Government to halt child abuse in Indigenous communities of the Northern Territory On 21 June 2007, the Australian Prime Minister, John Howard, announced the following measures to combat child abuse in Indigenous communities in the NT:1 Widespread alcohol restrictions on NT Aboriginal land for 6 months Medical examinations of all Indigenous children in the NT under the age of 16 years Quarantining of 50% of the welfare payments to parents of children in the affected areas for the purchase of food and other essentials Enforcing school attendance by linking income support and family assistance payments to school attendance for all people living on Aboriginal land Taking control of townships through 5-year leases to ensure that property and public housing are improved Requiring an intensive clean-up of communities to make them safer and healthier, by marshalling local workforces through Work for the Dole arrangements Scrapping the permit system for common areas and road corridors on Aboriginal lands Banning the possession of x-rated pornography in the proscribed areas Increasing policing levels, and making law and order a central focus of the measures announced Amending NT land rights legislation 2 The Anderson Wild report4 The 97 recommendations covered: Leadership by the federal and Northern Territory governments in consultation with Aboriginal people, government responses to ensure child safety, the role of the Family and Children’s Services program in the NT, and family support services; Health aspects, both crisis intervention and prevention through primary health care; Policing, police education, cooperation with the Family and Children’s Services program, support for victims, bail applications (when the alleged offence is sexual abuse of a child), and offender rehabilitation; School attendance, the role of communities, community education and awareness, and housing; Alcohol and other substance abuse, pornography, and gambling; Community justice; Cross-cultural training of staff; and Implementation of the report.

Ian T Ring MB BS, MSc(StatsEpid), FAFPHM · Mark Wenitong BMed

Reform is needed, but will the current Bill enact the best options? Two articles in this issue of the Journal1,2 comment on a complex but important piece of legislation put forward by the Minister for Health and Ageing — the National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2007 (the Bill).3 The Bill splits the Pharmaceutical Benefits Schedule into two formularies: “one part for single brand drugs [F1], the other part for drugs that have multiple brands or that are interchangeable at the patient level with drugs with multiple brands [F2]”.3 The Bill allows reference pricing of drugs within each formulary but disallows an ongoing link in the price of drugs between formularies. The Bill institutes progressive mandatory price reduction and price disclosure by the sponsors of multiple brand (generic) medicines for drugs on F2. The aim of this is to ensure that the price the government pays for Pharmaceutical Benefits Scheme (PBS) medicines more closely reflects discounted prices paid by pharmacists and international prices for generic medicines. A support package will be provided to help community pharmacists adjust to the new arrangements. Authority approvals will be streamlined, a public awareness campaign is promised to promote the use of generic medicines, and a working group will be established to consider issues of continued access to innovative medicines through the PBS. The government argued in the Bill that dual delinked formularies were required to tackle a problem caused by reference pricing: price reductions imposed on multiple brand generic medicines that were being discounted to pharmacies would, in many cases, flow directly on through price linking to single brand patented medicines that were not being discounted. This was said to cause difficulties for the innovative pharmaceutical industry and to place patients at risk of losing subsidised access to many worthwhile medicines.4 The government believes patients will not be disadvantaged by the proposed changes, as out-of-pocket costs to patients would remain unchanged. In some cases, patients should pay less. It is estimated that the mandatory price reductions for drugs in the F2 formulary will result in patients paying between 20 cents and $4.65 less for about 400 drugs that will fall below the current copayment amount of $30.70 (for general patients), or that were already below this amount. The articles by Searles et al1 and Faunce2 raise three concerns about the Bill. First, eliminating global reference pricing could result in Australia paying more for a new medicine in F1 that is no better than those already available in F2. Second, these changes appear to reflect ongoing pressure from the United States through the Medicines Working Group established by the Australia–US Free Trade Agreement to weaken the PBS system of evidence-based reference pricing. Third, mandatory price reductions and price disclosure for drugs on the F2 formulary, while saving the government money, provide little financial relief to patients and are unlikely to stimulate the Australian generic medicine industry. Reference pricing is a means of negotiating a lower price by tying the subsidy to the differential effectiveness of the drug — its comparative clinical outcome rather than its cost of production. This principle applies both at the time of initial subsidy and later, when new competitors arrive on the scene. The proposed changes may not change the initial pricing mechanism, which will continue to use comparative effectiveness as a criterion for pricing. What they will do is lessen the “downward pressure” on single brand (patented) drug prices over time. With the new dual formulary system, there will no longer be an automatic price reduction when different drugs of similar effectiveness for the same condition are listed on the PBS at a lower price. The problem with the current system, as Searles et al make clear, is that we are paying too much for drugs that are out of patent, where the company has already made its profit on the initial investment. We need a means to reduce the price of generic drugs in a system where fixed out-of-pocket costs to consumers and historic negotiated prices with suppliers provide no incentive to switch to generics, and where there are no competitive forces to reduce prices to government. The Bill does provide one mechanism to do so. It will mandate price reductions to government for out-of-patent medicines over time. This will lower the cost of generic drugs in Australia — a much needed reform. The problem is that it relies on annual administrative rule changes that do little to encourage the generic medicine industry and may have the effect of maintaining high prices for patented medicines, even when similar non-patented drugs are falling in price. The unforeseen result might be that we will pay more for the health gains from many new expensive medicines over time. Searles et al suggest one alternative — maintain a single formulary, but have closed-bid, competitively tendered contracts with generic medicine suppliers to provide key drugs outside of the PBS. Another option would be to increase competition for generic drugs (within a single or dual formulary) by allowing generic drug manufacturers to discount to government rather than wholesalers or pharmacies. A generic-brand price discount to consumers could be seen as an extension of the current brand price premium scheme — instead of consumers paying more than the regular copayment for a particular brand, they could pay a lower price if they choose a particular generic. Using a market price signal of a copayment reduction for consumers is likely to be more effective in stimulating generic medicine use than the proposed government advertising campaign, possibly a lot cheaper, and is consistent with the aim of the National Medicines Policy to provide timely access to the medicines that Australians need, at a cost patients and the community can afford. Fine-tuning such a system so that the expected increase in market share would be enough to encourage a local industry, or to ensure the kind of continuous price reductions that the Bill imposes, is something that the government could experiment with — without serious disruption to the system. A Senate Committee inquiry into the Bill held a public hearing on Friday 15 June 2007, and was required to report the following Monday. The Committee recorded that this provided insufficient time to analyse specific concerns raised in evidence, especially in relation to possible long-term impact of these reforms. The Senate Committee recommended that the Minister report to the Senate 12 months after implementation of the reforms on their impact, par-ticularly on the cost of medicines to consumers.5 The Bill was amended accordingly.

Ken J Harvey MB BS, FRCPA · Anthony H Harris MA, MSc · Liliana Bulfone BPharm, MBA, GradCertHealthEco

As practice continues to evolve, there will need to be concurrent changes in undergraduate and postgraduate medical education on skin cancer Over the past two decades, preventive health programs about the need for sun protection have alerted patients to the significance of increased rates of skin cancer in white Australians. Skin checks of both affected people and the “worried well” have become daily medical practice. This public demand has resulted in changes to medical practice and an increase in associated health costs, as touched on in two other articles in this issue.1,2 In this editorial, I argue that, as practice continues to evolve, there will be a need for concurrent changes in undergraduate and postgraduate medical education on skin cancer. Each year over 300 000 Australians are diagnosed with melanoma or non-melanoma skin cancer.3 However, on clinical examination, it is not always easy to tell the difference between benign lesions and skin cancer, even with specialist training. Both patients and medical practitioners feel the pressure to excise lesions if there is doubt about their malignancy. In this issue of the Journal, Youl et al report that a quarter of the number of lesions removed were as a result of patient insistence.1 For every melanoma excised, about 20–25 benign pigmented lesions are excised,1,4 amplifying surgical and pathology costs — nearly 300 000 benign naevi were excised over the period July 2005 to June 2006.5 Further, Askew et al demonstrate that skin cancer excisions are increasingly associated with complex and expensive surgical repairs.2 Medicare Australia statistics show that procedural cryotherapy for 10 or more solar keratoses was performed 595 568 times between July 2005 and June 2006.5 Skin cancer has been reported as the costliest of all cancers to treat.6 Traditionally, actinic lesions were initially managed by general practitioners, with appropriate referral to dermatologists, surgeons and radiotherapists. If GPs were uncertain about skin cancer diagnoses, they would refer patients to specialist dermatologists, who often had long waiting lists, were variably accessible, and charged higher fees. The Australasian College of Dermatologists (ACD) has long recognised the skin cancer “epidemic” in Australia, but has had difficulty meeting patient demand for dermatologists’ services, even with a trebling of the number of trainees from 20 in 1976 to 65 in 2006 (ACD, unpublished data). With a minimum 4-year training scheme, the number of practising Australian dermatologists has only risen from 136 in 1976 to about 350 in 2006 (ACD, unpublished data). Most people in metropolitan areas will have to wait for weeks or months to see a dermatologist, while access to dermatologists in rural and regional Australia is variable. The College’s state facilities have created regional outreach clinics with rostered dermatologists, but services still need to be improved. The two-tier relationship between GPs and specialists has been challenged recently by the rapid growth of skin cancer clinics that bulk-bill patients and are staffed by non-specialist medical practitioners.7 There are no regulations about who can set up these clinics — some are part of large commercial corporations. Nor are there any particular requirements for training of the clinicians who work there. Thus, an under-regulated three-tiered system of skin cancer management has developed. From the patient’s point of view, the convenience, accessibility and billing arrangement of these clinics may be appreciated. But, patients may also be incorrectly assuming that the attending medical practitioners have had “specialist training” and be unaware that their usual GP may be just as competent.1 From a professional perspective, some skin cancer clinicians, realising that they may have a “credibility” issue with their colleagues, have started to form liaisons with universities to establish accreditation courses. These clinicians are the “standard bearers”, but we need to know the competence of all clinicians in all skin cancer clinics, which should be open to examination by the public and professional peers. In my view, the rise of skin cancer clinics and the partial “sidelining” of GPs in skin cancer management is due not only to the relative shortage of specialist dermatologists but also to a failure in undergraduate and postgraduate education on skin cancer. In the 1980s and 1990s, I believe there was a profound, long-term underinvestment in the number of Australian medical schools, accompanied by variability in the breadth and quality of teaching on skin cancer. Over the next few years, owing to the development of new medical schools, the number of medical students graduating each year will almost double.8 Ensuring that skin cancer education is adequate will be an enormous challenge. Given the high prevalence of skin cancer in Australia, the Australian Medical Council should ensure that universities can sign off their graduates as competent in clinical recognition of skin cancers, as all interns will need this skill. This education needs to be significantly patient-based, to ensure that medical students have the chance to develop an appreciation of subtle clinical features. Available resources, including teachers as well as patients, are limited. New paradigms, educational technologies and collaborations will need to be established quickly.9,10 Going beyond basic recognition of lesions, skin cancer management is a complex issue, involving both procedural and pharmaceutical interventions. This requires supervised training, which should be undertaken by postgraduate clinicians who want to manage skin cancer. At the moment, further training for non-dermatologists who wish to increase their skills in this area is extremely ad hoc. Some universities have recently capitalised on the interest in skin cancer management by establishing skin cancer courses for medical postgraduates.7 These vary from weekend diagnostic certificate courses to year-long masters degrees, but, critically, may lack a significant component of face-to-face clinical contact with patients. While such courses may form an important part of future postgraduate skin cancer education, I believe the first priority of universities must remain the provision of undergraduate education. A different approach would be to look at more “hands-on” clinical training to achieve clinical competence in skin cancer management. The Royal Australian College of General Practitioners, the Australian College of Rural and Remote Medicine, and the ACD are working on a unique training and education scheme that will provide supervised clinical attachments and assess competence, but this program will take years to provide enough certified GPs. In the meantime, other GPs are establishing and publishing their credentials to manage skin cancer.2,3 There may be little difference in outcomes between competent experienced GPs and skin cancer clinicians.1 Public health studies have ensured that we are now aware that skin cancers are five times more common than all other cancers combined.6 Now the public needs to be assured that new medical graduates are able to recognise skin cancers and that postgraduate education institutes will ensure that clinicians who choose to treat skin cancer are appropriately trained and competent.

Christopher A Commens MB BS, FACD