Letters

To the Editor: Return to driving following a stroke is a complex issue. Austroads provides general guidelines1 and the National Stroke Foundation recommends a process including off-road and on-road driving tests.2 On-road assessments conducted by occupational therapists are considered the gold standard for decision making on return to driving following a stroke. Limited access is available to off-road and on-road tests across Australia, with few occupational therapists qualified to assess driving ability. Additionally, a range of off-road assessments are used for patients who have had a stroke. General practitioners, who are instrumental in managing return to driving, often base their decisions on limited information regarding functional status, particularly in terms of vision, cognition and perception. Rehabilitation physicians generally have access to more detailed information from allied health staff on which to base their decisions on driving ability. I investigated whether rehabilitation physicians’ recommendations on driving following a stroke were associated with patients’ performance on two objective tools, which could be used in general practice to assist with decision making. Participants were recruited at two rehabilitation services in Adelaide, South Australia, using the following inclusion criteria: had been diagnosed with stroke; had driven before the stroke; were aged over 18 years; and had provided written informed consent. I performed two assessments. The first was the Useful Field of View (UFOV) assessment;3 this is a computer-administered assessment that analyses processing speed, divided attention and selective attention, and takes 20 minutes to complete. The second was the Stroke Drivers Screening Assessment (SDSA);4 this consists of three tests conducted at a table — dot cancellation, compass recognition and road sign recognition — and takes 45–60 minutes to complete. Both assessments have been validated in patients who have had a stroke by comparison to on-road assessment.5 Treating rehabilitation physicians, blinded to assessment results, were contacted to obtain their recommendations on driving ability based on their clinical assessment and feedback from allied health staff at a case conference. A total of 123 participants (98 men [80%]) were recruited, and diagnoses included 53 right hemisphere strokes (43%), 63 left hemisphere strokes (51%) and 7 other strokes (6%). The participants’ mean age was 67.3 years (SD, 13.5 years), median period since injury was 42 days (range, 7–2190 days) and mean amount of driving experience was 48 years (SD, 14.9 years). Results of the SDSA (n = 120) and UFOV assessment (n = 123) were significantly associated with rehabilitation physicians’ recommendations on driving (Box). This suggests that referring patients who have had a stroke for one of these assessments would provide GPs with objective information to guide decision making on driving. With the introduction of Medicare Locals, resources that allow GPs to refer patients for standardised off-road driving tests should be considered. Rehabilitation physicians’ recommendations on driving for patients with a stroke diagnosis and results of two off-road assessments Rehabilitation physicians’ recommendations (number of patients) Not medically fit to return to driving On-road assessment required Return to driving — no on-road assessment required P SDSA results Pass (n = 61) 5 36 20 0.001* Fail (n = 59) 24 29 6 UFOV results Processing speed Pass (n = 97) 18 55 24 0.02* Fail (n = 26) 13 11 2 Divided attention Pass (n = 59) 10 33 16 0.22 Fail (n = 62) 19 33 10 Selective attention Pass (n = 82) 11 49 22 0.001* Fail (n = 39) 18 17 4 Overall risk category Pass (n = 80) 12 46 22 0.007* Fail (n = 41) 17 20 4 SDSA = Stroke Drivers Screening Assessment. UFOV = Useful Field of View. * P values of < 0.05 were considered significant and indicate an association between rehabilitation physicians’ recommendations and results of off-road assessments.

Stacey R George

To the Editor: We noted with interest the recent publication by Bismark and colleagues1 about complaint-prone doctors in Victoria. This research makes a valuable contribution to the important task of identifying practitioners who are at high risk of delivering poor quality health care. Similar analysis of more than 32 000 complaints received in Queensland from 1992 to 2010 has been undertaken by the Health Quality and Complaints Commission (HQCC). A summary of this work, which was performed in collaboration with the Medical Board of Queensland, was presented recently.2 Between July 2006 and June 2010, only 5% of medical practitioners registered as practising in Queensland were the subject of a complaint in a given year. Medical practitioners with multiple complaints (four or more complaints over the period; 0.7% of all medical practitioners) have substantially more complaints (> 2 SD) than their peers (average number of complaints, 1.6). An analysis of a subgroup of 117 doctors who were each the subject of multiple complaints revealed that they were more likely to be men, to have specialist rather than general registration, and to have an Australian rather than a non-Australian first qualification. Surgeons made up over 40% of this subgroup and were more likely to be the subject of a complaint than were other specialists. Further work is underway to clarify the level of complaints relative to the number of registered practitioners within each specialty. Although there are differences in the samples and analytical methods used in the HQCC study compared with those used by Bismark et al, there are striking similarities in the central findings: a small proportion of doctors produce a disproportionate number of complaints, and past complaint history is predictive of future complaint risk. Health complaints commissions in Australian states are working closely with the Australian Health Practitioner Regulation Agency to explore remedial or preventive opportunities. This task needs to involve the health care industry and professional colleges, as these complaint-prone practitioners are often well known by their colleagues or employers but, equally often, not adequately managed. As there is evidence that unprofessional medical student behaviour predicts both unprofessional doctor behaviour and risk of disciplinary activity,3-4 medical schools should also be engaged in this task.

Matt Vance · Michael Ward · David McKenzie

To the Editor: Were the views expressed by Conway and Savulescu really opposing?1,2 I turned to those pages with much interest, only to find that it seemed as if they would have been in agreement, had you put the scenarios they each describe to both of them. Conway discussed the conflict between doctor and patient about acceptability of the recommended management (the “best interests” of a dying child). In contrast, Savulescu talked of irrational prejudices held by doctors on the grounds of race, sex and other factors. Indeed, unless I missed some subtle points, I could not see any opposition in their arguments. I was, therefore, stumped when your online poll asked me to vote on the question: “Do doctors have the right to refuse certain treatments on the grounds of personal conscience?” Is the question asking about Conway’s point about what the doctor sincerely, on medical grounds, considers to be in the patient’s best interests, or is the question asking about a doctor’s refusal to attend to a patient on the basis of some irrational prejudice? Horses of quite different colours — racing in different races.

Peter C Arnold

To the Editor: Alcohol misuse is one of the leading causes of preventable death, illness and injury in Australia because too many Australians drink too much alcohol too often. The evidence is clear on what are the most effective strategies to curb alcohol misuse at a population level.1 By far the most effective of these is increasing the price of alcohol by increasing alcohol taxes. Aside from some positive features, such as lower tax on low-alcohol and mid-strength beer and the higher tax on alcopops, the alcohol taxation regimen in Australia is flawed from both an economic and public health perspective. A review of the tax system led by Secretary to the Treasury, Ken Henry, concluded that “current taxes on beer, wine and spirits are incoherent”, and recommended taxation reform using a volumetric tax.2 The response from the federal government to this review has echoed the failures of previous Australian governments to avoid increasing taxes. An independent coalition called the National Alliance for Action on Action (NAAA) has been formed with the goal of reducing alcohol-related harm.3 The NAAA represents a broad-based alliance of major health and community organisations that advocate for more effective responses to Australia’s drinking problems. Recognising that there is no single solution, the NAAA has focused on three priority areas: alcohol pricing and taxation; alcohol marketing and promotion; and alcohol availability. The Australian Government’s national tax forum held on 4–5 October 2011 in Canberra was an ideal opportunity for an informed discussion about alcohol tax reform. However, despite acknowledgement by the government that the current system does not effectively target the health and social costs of alcohol abuse, alcohol taxation was not part of the tax forum agenda.4 This was disappointing. At an NAAA day of action on 6 July in Canberra, assurances were given by Treasurer Wayne Swan and Health Minister Nicola Roxon that alcohol tax would be discussed at the forum. These assurances were aired publicly and in a number of media forums. The forum discussion document indicates that this promise was not honoured.5 This complex issue has not been resolved. We feel it is vital for the health and wellbeing of the Australian community that the reforms recommended by the Henry review remain on the political agenda.

Christopher M Doran · Wayne D Hall · Brian R Vandenberg · Todd A Harper · Jane E Martin · Mike Daube

To the Editor: I read with interest the contrasting perspectives by Pirotta1 and Dwyer2 on the ethics of prescribing complementary and alternative medicine (CAM) interventions, and the subsequent letters on this subject published in the 17 October 2011 issue of the Journal. Individual CAM interventions should be assessed with the same evidence-based approach we would use for any other intervention. Furthermore, any evidence should be interpreted with the same caution as we do for conventional medicines. The efficacy of an intervention should be judged by the quality of the clinical evidence in the context of its scientific plausibility. Whether an intervention should be recommended depends on the context of the other known evidence-based management strategies and the patient’s individual clinical scenario. It is concerning that the supporters of the use of CAM in general practice appear to be willing to make recommendations for treatment in the absence of quality empirical evidence. Both Pirotta and Kotsirilos make the often-used argument that absence of evidence is not evidence of ineffectiveness.1,3 Pirotta suggests that we can turn to tradition1 and Kotsirilos implies that consumer demand indicates effectiveness.3 It should be acknowledged that both tradition and popularity are unreliable forms of evidence. The absence of quality evidence for an intervention should be a major barrier to recommending it, especially when known, effective alternatives exist. This is regardless of the philosophical tradition of the intervention. Even when there is evidence for efficacy, care must be taken in avoiding overreaching conclusions. For example, Kotsirilos interprets the relevant Cochrane review4 as supporting the use of cranberry for prevention of recurrent urinary tract infections in young women.3 That therapeutic recommendation is unjustified. Although the systematic review did find some evidence for cranberry, it noted problems with its quality and the lack of clarity of dosage and administration. The conclusion of the review in 2008 was that “further properly designed studies with relevant outcomes are needed”.4 A well designed randomised controlled trial was published earlier this year; it does not support the use of cranberry for this indication.5

Chun Wah M Tam

To the Editor: We recently reviewed the individual policies of seven Australian tertiary maternity hospitals, from across all states, regarding neonatal vitamin D supplementation. An Australian 2006 consensus statement concerning the treatment and prevention of vitamin D deficiency in children and neonates identified the need to implement vitamin D supplementation in neonates born to mothers with serum 25-hydroxyvitamin D (25-OHD) levels of ≤ 50 nmol/L.1 Despite this, we found that a number of institutions have recently adopted a policy of treating infants of mothers with an antenatal serum 25-OHD level of < 75 nmol/L. Treatment of the neonate is with oral stoss therapy (50 000 IU vitamin D as a single dose) and/or daily oral vitamin D therapy (1000 IU) until cessation of breastfeeding. It should be noted that previous research has suggested that a substantial proportion of Australian women of childbearing age have a serum 25-OHD level < 75 nmol/L.2 Vitamin D is a pleiotropic hormone that influences the expression of more than 200 human genes.3 It has a wide range of biological actions, and the full implications of vitamin D supplementation during early life are unknown. While it is clear that very low levels of vitamin D are associated with abnormal bone development and the risk of hypocalcaemic seizures, it is also possible that vitamin D supplementation may have adverse effects. For example, we and others have found that a history of vitamin D supplementation during early life may be associated with an increase in allergic outcomes such as asthma and hayfever in later life.4,5 These are observational findings, limited by potential confounding and reverse causation, but they highlight the potential concern of changes in medical practice without an accompanying updated evidence base. There is an urgent need for improved data and further debate before implementing a public health policy affecting as many as half of all Australian infants. In the interim, we would advocate treatment of neonates only if they fall within the 2006 guidelines (mother’s serum 25-OHD ≤ 50 nmol/L).

Kate M McCloskey · Natalie Wright · Anne-Louise Ponsonby · Peter J Vuillermin

To the Editor: The article by Baade and colleagues1 is valuable, but further research on clinical interventions and outcomes, as well as collaboration with other stakeholders, is required to improve care. The main result of Baade et al’s analysis of Queensland-wide population-based data was that overall survival of patients with rectal cancer decreases as distance from radiotherapy services increases. The article is important because it documents variation in overall survival of patients with rectal cancer according to where they live. Documenting outcome variation is a necessary first step along the path to improving service delivery. As Baade et al discuss, the next step is to identify the cause(s) of the variation. This next step could usefully investigate the quality of surgery. Non-randomised studies have shown that high-quality surgery with total mesorectal excision (TME) improves overall survival in patients with rectal cancer.2 In contrast, neoadjuvant or adjuvant radiotherapy has not yet been shown to improve overall survival, although, as Baade et al note, randomised controlled trials (RCTs) have shown reduced rates of local recurrence, with a corresponding improvement in disease-free survival.1 However, some experts have questioned the extent to which decreases in local recurrence rates, as measured in RCTs, lead to improvements in overall survival (given high-quality TME).3,4 Also, radiotherapy is not without risk (eg, sexual dysfunction, incontinence, bowel obstruction). Whether an individual patient (in consultation with his or her doctor) decides to have radiotherapy will depend on how he or she judges the trade-off between benefits and harms.4 In other words, identifying the cause(s) of variation in overall survival for patients with rectal cancer will not be easy because of the subtleties of everyday clinical practice. Moreover, the subsequent and final step in the pathway — implementing interventions to reduce unwarranted variation — is also not easy. We could make faster progress if there were closer collaboration among researchers in universities or institutes (who can generate new knowledge), budget holders in government (who can do something about modifiable causes of variation), and clinicians (who will be at the leading edge of any changes). A large amount of predictable health-services research is needed, and collaboration among researchers, budget holders and clinicians is as important as developing investigator-initiated ideas for research projects. Faster optimisation of service delivery could be achieved if budget holders were less suspicious of the motives of research groups,5 and if research groups put more emphasis on asking budget holders, “How can we help?”

Michael D Coory

To the Editor: We find ourselves in the curious position of criticising an article that supports improving access to radiotherapy. Baade and colleagues looked at cause-specific survival in all patients aged 20–79 years diagnosed with rectal cancer in Queensland.1 They found a 6% increase in cause-specific mortality risk for each 100 km increment in distance from the nearest radiotherapy facility. They concluded that the apparent poorer outcomes were due to a failure to receive radiotherapy. However, we suggest that their approach was significantly flawed in a number of ways. We have difficulty in understanding why, when information about the use of radiotherapy is available, this key explanatory factor was not actually measured. The size of the benefit they attribute to greater use of radiotherapy exceeds the expected improvements attributable to adjuvant radiotherapy compared with none at all.2 The authors state that pathological staging, another factor central to their analysis, is a reliable surrogate for clinical staging. However, they appear not to have made any allowance for the fact that neoadjuvant treatment leads to pathological down-staging. Finally, the main outcome, cause-specific survival, was taken from death certificates and is likely to be inaccurate. Use of radiotherapy is suboptimal in Australia.3 If the authors could identify the impact of distance on access to radiotherapy, this would be very valuable for cancer service planning. Clinical input is desirable in future investigations in this area.

Sean A Bydder · Nigel A Spry

In reply: We thank Bydder and Spry for their comments, although we suggest that they have misunderstood our study and its conclusions. We appreciate the opportunity to clarify our results. Our study provides clear evidence that, after rectal cancer diagnosis, differences in survival are directly correlated with how far patients live from radiotherapy facilities.1 We did not conclude, as stated by Bydder and Spry, that “the apparent poorer outcomes were due to a failure to receive radiotherapy”. This explanation would be simplistic and ignores the many, varied and complex factors (demographic, socioeconomic, geographical and clinical) that together contribute to poorer survival in regional and rural communities. Cause-of-death codes were based on case reviews by specialised coders using clinical information, in addition to the death certificate. Information on clinical stage is not available in population-based cancer registries and, for some cancers (including colorectal cancer), staging based on pathology reports has been shown to be a reliable substitute.2 Population-based data on radiation treatment are not available in Queensland. Finally, whether or not distance from radiotherapy facilities has a direct impact on access to radiation treatment, while outside the scope of our study, is an important question and, with our clinical collaborators, is indeed one focus of the next phase of our work.

Peter D Baade · Paramita Dasgupta · Joanne F Aitken · Gavin Turrell

To The Editor: Bellomo quite rightly points out that medicine is now in an era when it is recognised that the amount of evidence being generated far surpasses most individual doctors’ ability to adequately deal with it.1 He suggests that “knowledge management may now be one of the major challenges of modern medicine”. However, is this a problem only needing to be confronted by those in medicine? I would suggest that it needs to be confronted by the Australian health care system as a whole, because a learning health care system is attainable only through implementation of system-wide change.2 In the recent final report of the National Health and Hospitals Reform Commission, three out of the five levers for action required to create an agile and self-improving health system involve elements of knowledge management.3 Hence, there is now much that needs to be done to achieve appropriate knowledge management across the Australian health care sector. We first need to recognise that knowledge is not only evidence that is gleaned from scientific studies (explicit knowledge) but also involves knowing what others are doing (tacit knowledge), as well as building on experience.4 The term “knowledge management” refers to the capacity to manage all of this at an organisational level. Further, we need to determine whether knowledge management is a problem that can only be solved within Australia by more resources being given to national bodies,1 or whether more innovative approaches are required. As knowledge management is now an issue for all organisations in the health sector, there is much to be gained from adopting an organisational learning focus2-4 as well as by understanding that an alteration in values (and culture) is required.4,5 Widespread acceptance of the need to identify and disseminate best practices will be required, even if it involves using evidence from international organisations to prevent both redundancy and duplication of effort locally.2,4

Deborah J Verran

To the Editor: Health data can have an important role in alerting product safety regulators to consumer product-related injuries. Such injuries are a significant public health concern, with an estimated 173 000 incidents occurring each year in Australia, many of which require medical treatment.1 The new Australian Consumer Law (ACL; http://www.consumerlaw. gov.au), enacted in January 2011, increases safety requirements and recognises that industry members have an important injury prevention role. The ACL requires suppliers to report to the Australian Government when they become aware of serious injuries, illnesses or deaths associated with products they supply.2,3 Monitoring product safety issues under the ACL therefore relies on systematic reporting of injuries by consumers to suppliers, and by suppliers to safety regulators, although the extent of compliance is unknown. Given that medical treatment is an indicator of injuries serious enough to warrant mandatory reporting, monitoring of products involved in injuries that require treatment in hospital emergency departments is a logical place to focus initial attention. Australia currently has an array of injury data, such as emergency department data, morbidity and mortality data and specialised injury surveillance collections, that could be used for this purpose, without the need for new, expensive data collections. We conducted a pilot study of product-related injuries in children in Queensland, which identified significant potential for using existing injury data more effectively in product safety surveillance.4 A comprehensive national evaluation of routinely collected health data would enable product safety regulators to better understand and use these data. With a lack of exposure to the ACL in the health sector, clinical staff and injured parties may not be aware of reasons for and mechanisms of reporting product-related injuries. It is important that medical professionals are made aware of the law and informed about actions they can take to support this system. Engaging emergency department staff could be a first step for product safety regulators. This could be as simple as a well publicised free-call number or a dedicated email address that clinicians can use to access information or report injuries quickly, without the need to complete large amounts of paperwork. There are substantial opportunities for strengthening product safety surveillance in Australia using existing routine health information systems and timely reporting of clinically significant incidents. This is critical for ensuring a more strategic approach to emerging product safety issues, prioritising efforts and evaluating the efficacy of product safety initiatives, to reduce preventable injuries and deaths related to unsafe consumer products.

Kirsten McKenzie · Ruth A Barker · Deborah A Scott · Dave A Strachan

To the Editor: MELAS (mitochondrial myopathy, encephalopathy, lactic acidosis and stroke-like episodes) syndrome has not been reported previously in the Aboriginal Australian population. Here, we describe a patient with MELAS syndrome in this population. A 29-year-old Aboriginal Australian woman presented with a 3-day history of seizures and confusion and a background of cognitive impairment, sensorineural deafness, epilepsy and short stature. On admission, she weighed 29.9 kg and was 1.46 m tall (body mass index, 14 kg/m2). She had myopathic facies, generalised mild motor weakness (4/5) and brisk reflexes (3+). These neurological findings represented a stepwise deterioration from previous assessments. On admission, the patient’s blood count, liver function tests, and serum urea, electrolytes and creatinine levels were normal. Her plasma bicarbonate level, anion gap and thyroid function were also normal. The patient had elevated resting arterial lactate (2.7 mmol/L; reference interval [RI], 0.7–2.5 mmol/L) and pyruvate (98 μmol/L; RI, 30–90 μmol/L) levels. The cerebrospinal fluid (CSF) protein concentration was 820 mg/L (RI, 150–500 mg/L) and the CSF lactate level was 5.4 mmol/L (RI, 0.7–2.5 mmol/L). Magnetic resonance imaging of the patient’s brain demonstrated increased T2 signal involving grey and white matter throughout both cerebral hemispheres, most confluent in the right temporal and parietal lobes (Box 1, A). An electroencephalogram displayed a slow rhythm with epileptic activity in the temporal and centroparietal regions. Histological examination of a biopsy of the gastrocnemius muscle was consistent with MELAS syndrome (Box 1, B). Electron microscopy of a muscle biopsy sample revealed mitochondria with abnormally arranged cristae and abnormal electron densities. Mitochondrial respiratory chain enzyme studies on muscle samples were within normal limits, but the common m.3243A>G mutation in the MTTL1 gene was detected in about 70% of the mitochondrial DNA (mtDNA) in muscle tissue and in 10% of the mtDNA of the peripheral blood. MELAS syndrome is a maternally inherited multisystem disorder resulting from mutations in mtDNA.1 Mitochondrial dysfunction leads to the clinical phenotype and lactic acidosis. Cerebral ischaemia unrelated to vascular territories is suggestive of the diagnosis,2 which is confirmed by genetic studies, enzyme assays and histological examination of affected tissue.3 The patient’s family was of Aboriginal Australian descent and she was not aware of any European ancestry. Further inquiry revealed a family history of deafness, diabetes and epilepsy (Box 2). Consequently, the family were offered genetic counselling. A literature review prompted initiation of arginine and coenzyme Q10 therapy.3 Twelve months later, she had good seizure control and had not been re-hospitalised. The disproportionate differences in health between Indigenous and non-Indigenous Australians are often appropriately ascribed to environmental factors. However, potentially treatable causes should always be considered. 1 Magnetic resonance imaging (MRI) and muscle histological studies A. T1-weighted MRI of the brain showing atrophy and enhancing low attenuation lesions. B. Gomori trichrome stain showing a ragged red fibre (black arrow) and two severely atrophic denervated fibres (white arrow). 2 Pedigree of the family of the patient (arrow)

Luke J Conway · Thomas E Robertson · James J McGill · Josh P Hanson

To the Editor: The editorial by Newman and colleagues on suicide and self-harm in immigration detention1 was a timely reminder of a contemporary issue that has aroused clinical, sociological and political debate. However, in providing a list of dot points for investigation, there was one curious omission. Although perhaps not politically correct or indeed comfortable for the authors, the well recognised possibility that suicide and self-harming behaviour could be politically motivated2 should also be addressed. This is important, not only because we as health professionals could be seen to be naive to ignore this, but, more specifically, so that inappropriate medicalisation of readily understandable distress does not occur.

Robert D Goldney

In reply: We thank Goldney for his thought-provoking response. We recognise that self-harm has multiple determinants, including mental disorders, but that it also attempts to influence or communicate. Acknowledging the political context that has created and sustains this issue, we also note long traditions of politically motivated self-harm and suicide, for example, by self-immolation or hunger strike; and that political protests using these methods — lip-sewing, cutting and self-burial — have occurred in Australian immigration settings. Our belief, based on extensive clinical engagement, is that the motivation for most self-harm and suicide in Australian immigration detention is not primarily political, but anchored in detainees’ deep despair. Many say that by killing themselves, they will end their pain and no longer be a problem to themselves, the government or their loved ones. As clinicians, we experience a tension — we acknowledge, with Goldney, the importance of not medicalising an area where the environmental and contextual influences so overtly create and maintain distress, yet we have a duty of care to reduce the risk associated with such behaviour and distress, irrespective of their origins. A pre-eminent challenge for professionals working in such stressful environments is to remain open to these multiple influences. We remain open to what the data will tell us about political and other contributing factors.

Michael J Dudley · Nicholas G Procter · Louise K Newman

To the Editor: In 2006, the Cancer Institute NSW established a single ethics committee, in order to improve the efficiency of ethics reviews for multicentre cancer clinical trials. This predates the National Health and Medical Research Council (NHMRC) Harmonisation of Multi-centre Ethical Review (HoMER) but exemplifies what HoMER aims to encourage nationally. Previously, such trials were submitted to each institution’s ethics committee, resulting in replication of effort and cost and prolonged review times, potentially making sites uncompetitive in attracting clinical trials.1 Under the Cancer Institute’s model, with the agreement of individual institutions, multicentre projects are submitted directly to a single ethics committee. Governance issues, such as the capability of an institution to provide appropriate support, and insurance issues have remained local health unit responsibilities.2 Data were prospectively collected on applications received from 1 July 2007 to 30 June 2009, and their processing times. The Australian Research Ethics Database was used to track and manage multicentre research projects. The aim was to achieve a 60-calendar-day time period from submission (1 month before the ethics committee meeting) to approval. Submissions were made on the NHMRC National Ethics Application Form, along with a protocol and patient information form. We evaluated 89 studies from the 2-year period. Fourteen trials were reviewed from single sites before other sites were engaged or whose ethics committees lacked cancer expertise. The median time range for review was 61–70 days. Forty-four per cent of applications were reviewed within 60 days and 70% within 80 days, ranging from eight studies taking 31–40 days to the extreme of seven studies requiring 131–160 days. The median time for assessment improved as the committee streamlined its processes: from 89 days in 2007 to 68 days in 2008 and 59 days in 2009. There were 15 studies, predominantly in the first year, that had long assessment times because of multiple issues concerning research merit and inadequate information for participants. Of the studies evaluated, one was approved without revision, 48 required minor revisions that were approved between meetings, and 40 required review by the full committee. Eighteen studies were reviewed twice, and 22 were reviewed more than twice. Efficiencies introduced included disseminating all documentation electronically, empowering the chair and deputy chair to approve minor amendments or responses between meetings, and the website carrying standard wording for use in sections of the patient information forms that were proving to be recurrently problematic. To resolve difficult issues that correspondence had not resolved, investigators were invited to meet with the committee. We conclude that a single ethics review for multicentre trials may be able to deliver a rapid response and be efficient without compromising ethical rigour. However, to make a difference to researchers, the governance review process will need to become correspondingly efficient. Our experience parallels that internationally, where such ethics committees can demonstrate cost savings with faster response times, yet provide ethical reviews of similar quality.3,4,5

Ian N Olver · Sharon J P Falleiro · Marion L Marson · James F Bishop

To the Editor: I am responding to the letter from McIntyre and colleagues in which they strongly urged the National Health and Medical Research Council (NHMRC) to increase support for primary health care research.1 Primary health care research is essential to the future of the Australian health system. Unfortunately, few primary care researchers apply to the NHMRC for support. Reflecting our concern about the low application numbers, we held a workshop on primary health care research last year (see http://www.nhmrc.gov.au/media/events/2010). Our statistics show that from 2008 to 2010, just 1% of total applications to the NHMRC for project grant funding designated the field of research as primary health care. The overall success rate for these primary health care grants over the period 2008–2010 (24%) compares favourably with the overall success rate for all project grants (24%) and clinical research project grant success rates (20%) over the same period. It is notable that the annual number of primary health care grant applications peaked early in the decade and have plateaued since 2004 (Box). This possibly reflects the additional funding for primary health care research from other sources, notably the Australian Primary Health Care Research Institute (APHCRI), which has funded a number of research projects since 2001. In 2010, the APHCRI announced funding of more than $3 million in the form of three centres of research excellence,2 four project grants3 and four fellowships.4,5 Number of National Health and Medical Research Council project grant applications with the field of research as primary health care, 2000–2010 Application year No. of applications 2000 7 2001 5 2002 58 2003 42 2004 31 2005 27 2006 28 2007 20 2008 30 2009 30 2010 30

Warwick P Anderson

To the Editor: The letter by Johnson and Mitchell,1 responding to the two published papers of Rosenwax2 and Lowthian3 and their colleagues, about hospital, ambulance and emergency department use in the last year of life, concluded with the statement: Also essential is an ongoing dialogue with the patient and family to enable a clear understanding of the goals of treatment and to proactively plan for likely adverse events . . . [this] will potentially reduce the use of acute services and encourage the provision of care in more appropriate environments. The most significant factor in facilitating this latter objective is the timely preparation by the patient of the appropriate form of instructions to medical staff and designated family members about end-of-life management. Unfortunately, there is no common, state-recognised instrument for this in Australia. Many people appear to believe that conferring a “power of attorney” on a family member is all that is required, but this is not the case. In most situations, this allows the designated member or members to administer financial and property matters but not to make medical decisions about end-of-life care. The requirements for a valid medical decision-making authority differ from state to state. The instruments are variously known as: “enduring power of attorney” in the Australian Capital Territory; “enduring power of attorney (medical treatment)” in Victoria; “medical power of attorney” in South Australia; “enduring guardianship” in New South Wales and Tasmania; “enduring power of guardianship” in Western Australia; “advance health directive” in Queensland; and “medical enduring power of attorney” in the Northern Territory. It would be a major advance in the rational use of health resources, and towards ensuring compliance with the wishes of people who are terminally ill, while minimising the stress and distress of their family members, if general practitioners were to encourage their chronically and terminally ill patients to complete the appropriate form early in their illness.

John D Paull

To the Editor: In 1999, a new medical school was established at James Cook University in an underserved region with specific needs in rural, remote and Indigenous health.1 Early data suggest graduates are contributing to the local workforce,2 but medical student places have increased further as part of the continued expansion of Australian medical education. As a result, the capacity for medical students to experience high-quality clinical opportunities is under challenge. We explored teaching capacity through a cross-sectional survey of inpatient workload at a private and a public teaching hospital in Townsville. Both hospitals have been established as major teaching sites for the past decade. Ward audits were conducted for almost 400 inpatients, followed by content analysis of primary and additional diagnoses obtained from hospital records. We found that in both hospitals, only about half the total number of beds contained patients who were well enough for medical student interactions, and only around half of these patients were available to the students. Overall, the clinical casemix indicated students had reasonable access to patients with a wide range of medical problems. However, the data also showed poor exposure across both hospitals to certain subspecialties, and relatively low exposure in the private hospital to more chronic and complex medical problems. These findings suggest the potential numbers of meaningful learning opportunities per student may be fewer than expected. Growing student numbers have coincided with expansion in the emergency department, and same-day, early discharge and hospital-in-the-home services. Further, surrounding rural hospitals are being better utilised as step-down facilities for rural residents. These innovations have resulted in a decrease in the average length of stay in the main hospital wards.3,4 Although increased throughput of patients may theoretically increase teaching capacity, it is likely that higher turnover also results in students missing opportunities for holistic learning, such as practising routine history taking and examination skills, and developing a social understanding of a patient’s illness episode. About 300 inpatient beds are currently being added to the public hospital. Based on our findings, this could translate into about 75 additional patients on any given day. However, the number of medical students has now doubled to over 200 per year. The findings suggest that, at least in one regional area of Australia, hospitals face significant constraints in expanding their clinical teaching. This may have implications for medical schools in other regions. General practices and rural hospitals may also be close to capacity.5 Therefore, we recommend that Australian medical schools plan carefully and strategically to ensure students gain access to sufficient clinical experiences. With support from the Health Workforce Australia initiatives, opportunities to innovate and expand in non-traditional clinical settings may provide a partial solution, but will require evaluation.

Tarun Sen Gupta · Richard B Hays · Torres S Woolley · Isaac Seidl · Andrew Johnson

To the Editor: Faunce and colleagues wisely called for the introduction of legislation modelled on the United States False Claims Act (FCA) in the Australian health care setting.1 Indeed, whistleblowers require protection and reward.2 The authors stated that the “key strengths of the US qui tam anti-fraud regime ... lie in its recovery of large amounts of public monies, its encouragement of good corporate practice” and noted that it is “largely compensatory or remedial rather than punitive”.2 However, the non-punitive nature of the regime is problematic. Settlements in the US may appear substantial. In 2009, Pfizer paid US$2.3 billion to settle a false claims action against their marketing of Bextra (valdecoxib).1 However, this sum represents only a small proportion of Pfizer’s overall profits, given that Bextra was marketed from 2001 to 2005 and the company’s profit for the first quarter of 2011 was US$2.2 billion.3 Clearly, pharmaceutical companies in the US cope with the FCA — their huge profits largely compensate for the settlements. “While the defense industry used to be the biggest defrauder of the federal government under the FCA ... the pharmaceutical industry has greatly overtaken the defense industry in recent years.”4 Between 1991 and 2010, settlements for criminal and civil monetary penalties reached a total of US$20 billion. Three-quarters of these occurred between 2006 and 2010.4 The message from the US experience is that non-punitive anti-fraud laws do not stop pharmaceutical companies from engaging in fraudulent activities.

Alain Braillon

To the Editor: Recent articles in the Journal have noted the first case of extensively drug-resistant tuberculosis (TB) in New Zealand,1 and emphasised the exponential increase in cost and complexity of managing drug-resistant TB.2 We thus wish to caution against the proposed premature closure of TB treatment services for Papua New Guinea (PNG) citizens who access health care in the Torres Strait Islands. A Protected Zone under the Torres Strait Island Treaty allows selected inhabitants from the South Fly District of Western Province, PNG, to conduct traditional practices in the outer Torres Strait Islands. Because access to health care in the South Fly District is difficult and local TB control is poor, many of these people use TB services in the Torres Strait Islands, which are under Australian jurisdiction. Around 60 PNG patients, 50 of whom have multidrug-resistant TB, currently receive treatment from Australian TB services for humanitarian and public health reasons — to limit the transmission of TB into Australia. This is especially important given the high rates of transmissible drug-resistant disease.3,4 We thus support the strategy of the Australian and Queensland governments, which aims to strengthen PNG TB control as the best long-term solution. However, establishing effective TB control in resource-poor settings such as PNG is complex and confounded by competing health priorities. We are very concerned by the assumption that care of all PNG patients with TB should be transferred back to PNG by February 2012. To avoid making TB control in this area even harder, and particularly to avert the emergence of extensively drug-resistant TB, with subsequent transmission to Australia, we believe that such transfer of care should be based on an objective assessment of the capacity of services to manage the increasing number of patients and the complexity of their treatment. The National Tuberculosis Advisory Committee — a subcommittee of the national Department of Health and Ageing’s Communicable Disease Network Australia — and the International Union Against Tuberculosis and Lung Disease, endorse the World Health Organization Stop TB Strategy,5 which places the responsibility for TB management on the jurisdiction where the case was diagnosed. This strategy should also be adopted by the federal and Queensland governments so that patients diagnosed within Australia are only transferred to places where they are likely to complete effective treatment, in accordance with International standards for tuberculosis care.6 This is the situation for illegal immigrants who are diagnosed with TB at the United States–Mexico border. We therefore recommend that: federal government funding to develop TB services in PNG should include operational research to identify the most cost-effective and pragmatic long-term solutions; and current Australian services within the Torres Strait be maintained to ensure cross-jurisdictional management of TB, with a gradual transfer only as capacity within PNG is increased. This position is widely supported by Australian clinicians involved in TB control.7

Anastasios Konstantinos · Graham Simpson · Tania C Sorrell · Ben J Marais

To the Editor: The approach of spring, together with high winter rainfall in and around Melbourne,1 heralds another severe pollen season, raising the risk of allergic rhinitis and asthma in pollen-sensitive individuals. It is therefore timely to report an epidemic of “thunderstorm asthma” that occurred in Melbourne during spring 2010. Thunderstorm asthma is the phenomenon of a sudden increase in acute asthma exacerbations temporally related to a thunderstorm.2 Previous epidemics in 1987 and 1989 saw up to 10-fold increases in asthma presentations to emergency departments across Melbourne over 24-hour periods.3 Those commonly affected are young adults with a history of seasonal allergic rhinitis but not necessarily asthma, and people with a previous diagnosis of asthma, many of whom do not use preventer medication.4 Rye-grass pollen is believed to be the major causative allergen in Melbourne thunderstorm epidemics.2 In Melbourne, this common springtime aeroallergen is generally filtered out by the nose due to its relatively large 20-micron diameter, causing allergic rhinitis in sensitised individuals. When exposed to moisture, such as in a developing storm cloud, osmotic stress can lead rye-grass pollen to rupture into submicronic particles that are respirable to the lower airways.2 Thunderstorms have outflow winds which concentrate these particles at ground level,4 resulting in epidemics of asthma in exposed, pollen-sensitive individuals. We analysed pollen counts and numbers of asthma presentations at the emergency department of Austin Health (a tertiary hospital servicing north-eastern Melbourne) in the days before and after the thunderstorm of 25 November 2010 (Box). There was a clear spike in asthma presentations immediately after the storm, similar in magnitude to previous epidemics.3 Although we report the experience of one institution only, this was a city-wide event that caused considerable media interest and implementation of the ambulance disaster response plan due to the large number of emergency calls received.5 Pollen counts were in the extreme range (> 100 grains/m3) during some of the days before the thunderstorm, but they were only moderate on the day of the storm (Box). Therefore, while pollen counts can be used as a guide for atopic individuals, they are not the only indicator of an allergenic environment. We propose that additional warnings of elevated risk of asthma exacerbations in pollen-allergic individuals should be made when springtime and summertime thunderstorms follow several days of high or extreme pollen counts. Individuals with seasonal asthma should use preventer medication, at least during spring, and should have an asthma management plan. Patients with allergic rhinitis should be warned of the possibility of new-onset thunderstorm asthma and advised to seek assistance rapidly if asthma symptoms manifest. Allergen immunotherapy may be administered in carefully selected individuals to prevent springtime symptoms and assessment of such patients by an allergy physician is recommended. Daily pollen counts in Melbourne and Austin Health emergency department presentations for acute asthma before and after a thunderstorm in Spring 2010* * Pollen count data were provided by Ed Newbegin, School of Botany, University of Melbourne.

Megan L Howden · Christine F McDonald · Michael F Sutherland

To the Editor: We write in response to the letter by Awerbuch1 and agree with many of his points. He has raised an interesting issue regarding the assertion that chronic pain is itself a disease,2 suggesting it would then logically follow that the patient becomes the final arbiter of whether he or she has the “disease” and hence which treatment may or may not be appropriate. A disquieting development in this regard is the recent Declaration of Montréal, produced at the International Pain Summit of the International Association for the Study of Pain in September 2010.3 This declaration states that access to pain management should be considered a fundamental human right. The position of diagnosis is uncertain, and the only specific treatment modality mentioned is opioid therapy. While we are sure that the Declaration is noble in intent, where does it place a clinician who has concerns about prescribing opioids to a patient who demands them? It adds the legal threat of a breach of human rights if the patient is disaffected with a doctor’s decision on opioid prescribing. As Awerbuch and others4,5 have stated, the public health consequences of prescribed opioids are not trivial. Assessing the appropriate circumstances for their use requires an understanding of clinical evidence and due care, not dogma, moral coercion or forays into jurisprudence.

Dilip Kapur · Phillip B Cornish · Carol A Snellgrove · David A Cherry

To the Editor: I would like to add some detail to the article by Shaw and colleagues1 on the costs of screening for diabetes and glycated haemoglobin (HbA1c) testing. At face value, using the 85% Medicare Benefits Schedule (MBS) rebate, the item for HbA1c testing costs $1.85 less than the item for a glucose tolerance test (more than 10% cheaper), but it is a little more complicated than these simple figures suggest. In 2010, 295 023 glucose tolerance tests (item number 66542) were claimed on the MBS — up 61% on the number ordered in 2004 (183 090)2 — which reflects the increase in ordering by general practitioners, who I believe are more aware of the increased incidence and prevalence of one of the most common chronic diseases in Australia. I also believe that it reflects the use of the glucose tolerance test as the definitive test for diabetes (rather than relying on a single fasting glucose level) in private practice. In contrast, 1 021 247 HbA1c tests (item number 66551) were claimed in 2010, versus 911 623 in 2004 — up by only 12% over the same 7-year period.2 This reflects “coning” of pathology items in the MBS. There are two types of cone that affect billing of HbA1c tests: the “grand cone”, which restricts billing to the three most expensive items ordered by a GP on a single occasion (regardless of the number of tests ordered), and the “temporal cone”, where only four HbA1c tests can be billed in any 1 year. The glucose tolerance test has no temporal restrictions and is usually performed on its own, so it avoids the grand cone, but the HbA1c test is often ordered with a bank of other tests (eg, as part of diabetes monitoring) and is thus not usually billed to Medicare. In my practice, only 30% of reported HbA1c tests can be billed to Medicare, hence the cost to Medicare per reportable test is about a third of the listed rebate of $14.40. Furthermore, as Shaw et al point out, HbA1c testing cannot currently be billed for the diagnosis of diabetes, although my personal observation is that many doctors are already using this as a screening test. There are essentially three powerful drivers for HbA1c testing: the increased prevalence of diabetes, the (honest) push to test HbA1c levels every 4 months (through care plans etc) and the use of HbA1c tests to diagnose diabetes. I believe that Medicare currently pays for less than 40% of these tests and that this proportion will fall as more HbA1c tests are requested. The majority of the costs for HbA1c testing are subsidised by pathology practices — which, philosophically, I find quite odd. These points need to be taken into account when undertaking a cost–benefit analysis of screening for diabetes in Australia.

Len D Moaven

To the Editor: The position statement by Jones and colleagues regarding the change of HbA1c reporting to the new Système International (SI) units — which has been recommended by the Australasian Association of Clinical Biochemists, the Australian Diabetes Educators Association, the Australian Diabetes Society and the Royal College of Pathologists of Australasia — provides a comprehensive summary of the rationale behind the proposed change and suggests a 2-year period of dual reporting.1 However, Jones et al did not specify targets for children and adolescents, and we believe that it is important to do so. The incidence of type 1 diabetes in Australian children and adolescents is among the highest in the world2 and, in New South Wales, type 2 diabetes represents at least 10% of cases of new-onset diabetes in adolescents.3 National evidence-based clinical care guidelines for type 1 diabetes in children, adolescents and adults4 include age-specific targets for HbA1c, while recognising that such targets are predominantly consensus based. HbA1c targets for young people with type 1 diabetes are higher, with a level of < 7.5% recommended for children and adolescents in the Australian guidelines4 and in those produced by the International Society for Pediatric and Adolescent Diabetes (ISPAD).5 Jones et al note that “Achievement of HbA1c targets must be balanced against risk of severe hypoglycaemia, especially among older people”;1 this is also the case for young people. For children and adolescents with type 2 diabetes, the ISPAD guidelines recommend an HbA1c target of < 7%.5 The move to SI units represents a major change in the established, widely recognised outcome measure of glycaemia; during the transition period, the specific needs of young people with diabetes must not be forgotten.

Maria E Craig · Kim C Donaghue · Fergus J Cameron · Martin Silink