Letters

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

In reply: We appreciate Craig and colleagues’ comments regarding the importance of reporting general HbA1c targets for children and adolescents with type 1 and type 2 diabetes. In our position statement, the headings of Box 2 and Box 3 indicated that the targets listed were for adults with type 1 diabetes and adults with type 2 diabetes, respectively.1 While it is not possible to highlight every clinical situation, we agree that providing general HbA1c targets for children and adolescents will add value to our article, and we have updated it accordingly,1 recognising the differences in these targets for type 1 diabetes (≤ 58 mmol/mol, ≤ 7.5%) and type 2 diabetes (≤ 53 mmol/mol, ≤ 7.0%).2-4 In the interests of uniformity and simplicity, the paediatric targets expressed as “<”2-4 have been adjusted to “≤”, which represents differences of less than 1.5% of the target values. Addendum p 524

Graham R D Jones · George Barker · Ian Goodall · Hans-Gerhard Schneider · Mark D S Shephard · Stephen M Twigg

To the Editor: My observations over the past 10 years as an ambulance paramedic are consistent with the growth in demand for emergency and non-emergency ambulance services in Melbourne.1 Strong demand has been forecast to continue because 60% of patients who are eligible for emergency transport do not currently use ambulance services.2 The increasing demand for ambulance services — an essential component of the Australian health care network — necessitates the development of valid, reliable indicators of quality and safety in prehospital health care, to maintain and improve the quality of that care. As part of the Australian Commission on Safety and Quality in Health Care’s National Indicators Project, the Australian Institute of Health and Welfare (AIHW) has proposed 55 indicators of quality and safety in health care that represent a whole-of-system approach.3 However, this cannot be achieved without the inclusion of ambulance indicators. The AIHW indicators focus mainly on facility-based services (eg, hospitals) and underestimate the interdependence of the health care network. Ambulance services routinely collect information from the wider health care community, representing transported and non-transported patients, including clinical intervention and outcome parameters. These data can be used to identify interventions and outcomes attributable to prehospital health care practice. Improvements in patient sequence management,4 based on Ambulance Victoria research and data from specialised trauma and cardiac arrest registries,5 suggest that ambulance interventions can result in tangible benefits. Ambulance-specific process and outcome indicators would enable more precise attribution of outcomes to prehospital care and assist in apportioning health outcomes across the wider health network. This would directly benefit hospitals because pressure for increased public accountability currently ascribes performance based on risk factors that hospitals cannot influence. Enhanced prehospital indicators could supplement and expand the range of risk parameters that hospitals currently use to adjust hospital performance indicators; this would help mitigate the limitations inherent in comparative public reporting.6 Longer-term benefits include the implementation of alternative models of evidence-based practice, encompassing “treat-and-leave protocols”, and identification of non-hospital referral avenues. Safety is a crucial aspect of alternative practices, and protocols must be formulated and monitored in the light of valid and reliable indicators. Inclusion of ambulance indicators in the National Indicators Project would place ambulance services in a key position to ensure that timely access to safe, high-quality health care is maintained and improved.

Paul A De Vincentis

To the Editor: The potential upper gastrointestinal morbidity associated with non-steroidal anti-inflammatory drug (NSAID) misuse is well known.1,2 Recently, Frei and colleagues3 provided an overview of the morbidity and patient characteristics relating to opioid–NSAID misuse; however, they did not identify those patients with NSAID enteropathy (NE). NE is thought to occur via NSAID-induced reduction of endogenous prostaglandin via inhibition of both cyclooxygenase (COX)-1 and COX-2. The result is altered mucosal integrity, which thereby allows exposure to noxious luminal contents leading to inflammation, erosion and ulcers.1 We underscore the importance of identifying this group of patients presenting with anaemia, hypoalbuminaemia, weight loss or abdominal pain that relates to NE. The clinical presentation and small-bowel ulceration that is noted on investigations can often mimic Crohn’s disease.4 As the patient’s drug misuse is not immediately apparent, the diagnosis eludes the treating physician for some time, potentially at the expense of further morbidity from both ongoing medication misuse and the iatrogenic consequences of repeated presentations, investigations and medications that have been initiated to manage Crohn’s disease. Within the Townsville Hospital v(a 460-bed tertiary referral centre for North Queensland), we have observed an increasing number of cases where patients covertly self-medicate with large doses (up to 20 tablets per day) of codeine–ibuprofen analgesics, taken mainly for codeine addiction, subsequently developing small-bowel abnormalities. We present three cases that highlight this problem (Box). In each of these cases, the NSAID use was not immediately apparent. A recent search on the Adverse Drug Reactions Advisory Committee database did not identify any reports of such patients. This may represent significant underreporting of the issue due to lack of physician awareness. In mid-2010, the National Drugs and Poisons Schedule Committee implemented changes to how over-the-counter combination analgesics containing codeine can be accessed.5 Such medications must be accompanied by product and consumer medicine information, and a pharmacist must be involved at every sale to record the customer’s details. Despite these changes, there are still potential pitfalls, as there is no mechanism in place to stop patients from “pharmacy hopping”. It may be necessary to reschedule codeine as a prescription-only substance, and to create real-time databases of over-the-counter sales. While these drugs remain accessible over the counter, patients will continue to use them. Clinicians should therefore be vigilant for evidence of NSAID impact on the gastrointestinal tract. Three patients who self-medicated with large doses of a codeine–ibuprofen analgesic with small-bowel abnormalities consistent with NSAID enteropathy Patient characteristics Presentation Medications Investigations NSAID self-medication 42-year-old man with chronic ankle pain; hypogonadotrophic hypogonadism; diverticulitis with paracolic abscess; cholecystectomy; appendicectomy; excessive alcohol use; depression Recurrent severe hypokalaemia; vomiting, abdominal pain and weight loss; iron deficiency and hypoalbuminaemia; vitamin B12 deficiency Omeprazole 40 mg/day; mirtazapine 15 mg/day; oxycodone 5 mg 4–6 hourly as needed Gastroscopy: antral ulcers; colonoscopy: normal; capsule endoscopy: multiple jejunal ulcers with early structuring consistent with NE; CRP level within RI Ibuprofen 200 mg/codeine phosphate 12.8 mg: 10 tablets/day 41-year-old woman with previous diagnosis of Crohn’s disease elsewhere, not supported by small-bowel resection Abdominal pain, diarrhoea and vomiting; iron deficiency anaemia; hypoalbuminaemia Iron supplement Gastroscopy and colonoscopy: normal; capsule endoscopy: multiple web-like strictures with circumferential ulceration throughout the small bowel consistent with NE; CRP level within RI Ibuprofen 200 mg/codeine phosphate 12.8 mg: 20 tablets/day for 5 years 41-year-old man with Scheuermann’s disease; chronic back pain; melanoma; depression; excessive alcohol use Iron deficiency anaemia; hypoalbuminaemia Omeprazole 40 mg/day; amitriptyline 25 mg/day; as needed: buscopan 20 mg; paracetamol 500 mg/codeine 8 mg; paracetamol 500 mg/codeine 30 mg; tramadol 50 mg Upper endoscopy: small gastric ulcer; push enteroscopy: multiple jejunal ulcers consistent with NE; CRP level within RI Ibuprofen 200 mg/codeine phosphate 12.8 mg: 10–12 tablets/day for more than 5 years CRP = C-reactive protein. NE = NSAID enteropathy. NSAID = non-steroidal anti-inflammatory drug. RI = reference interval, < 5 mg/L.

Rozemary Karamatic · John Croese · Enrico Roche

To the Editor: We agree with Smith and colleagues1 that it is important to raise awareness among health professionals — and consumers — about recently revised dosing recommendations for colchicine. Software decision-support tools have an important role in ensuring safe prescribing of such drugs. However, we have questions about whether this software uses information that is up-to-date with current evidence, particularly in relation to colchicine. We believe that the clinical software systems used by clinicians and pharmacists could better support them in relation to medicines safety issues like this one. First, they could provide up-to-date, evidence-based dosing information. Second, they could warn the user when potentially harmful drug doses are being prescribed or dispensed, or when there are new recommendations about drug therapy. In this case, the situation is not straightforward because there are inconsistencies in the dosing recommendations for colchicine. In 2010, an article in NPS RADAR highlighted new evidence to support the use of low-dose colchicine in acute gout.2 This new dosage regimen was also recommended in the Australian medicines handbook in 2010.3 Nevertheless, higher doses are currently recommended in the Australian approved product information (PI), the consumer medicines information leaflet, and other commonly used medicine reference sources (this raises other issues, including the fact that there is currently no process to ensure that the PI is regularly reviewed, and the role of the Therapeutic Goods Administration4; however, these are beyond the scope of this letter). There is no guidance for clinical software vendors regarding which information to provide, and, at present, drug dosage information in these systems is frequently based on the PI as provided by the manufacturer or sponsor. We examined colchicine dosing information provided at (or accessible from) the point of prescribing or dispensing in a number of commonly used systems, and none showed the recent low-dose recommendations. Nor were any alerts or warnings displayed about potential toxicity specifically related to the dosage regimen for colchicine. Our previous research has shown that, in general, there is little of this type of decision support available in general practice software.5 Guidance for software vendors and high-quality, up-to-date knowledge bases are required to support this functionality. Currently, there is no overarching governance mechanism in Australia to guide the development of decision support, or to ensure that the inclusion of clinical information in software is up-to-date or based on the latest evidence. A coordinated approach to ensure that these systems support safety and quality is long overdue.6

Michelle Sweidan · James F Reeve · Kitty Yu

To the Editor: The letter from Smith and colleagues in the 6 June 2011 issue of the Journal1 highlights the potential toxicity of colchicine, even when used in the therapeutic doses recommended in the current product information (PI).2 This in turn highlights how important it is that all medicines have PI that continues to be maintained with the most clinically accurate and up-to-date information. The current system for maintaining PI seems to break down most significantly with out-of-patent, “grandfathered” and “orphan” medicines.3 During 2009, we identified an important change in the recommended dose in the American PI for colchicine through our usual processes of scanning the medical literature (including the websites of drug regulatory agencies). Colchicine is an out-of-patent medicine. The American study underpinning the American PI changes was sponsored by a different company and used a strength of colchicine tablet (600 μg) not available in Australia.4 The local sponsor companies were contacted at the time, but did not plan to update their Australian PI. Amending a PI is a costly and lengthy process, and the expense is hard to justify for an inexpensive and relatively low-use product. We updated the Australian medicines handbook dosing information5 and then wrote to the Therapeutic Goods Administration (TGA) suggesting the PI change could be initiated by them in the public interest. As yet, we have not received a response from the TGA and the dose in the PI remains unchanged. Despite its limitations in cases such as these,3 the PI forms the backbone of default dosing and drug interaction data in electronic prescribing software in Australia.6 We hope that Smith and colleagues’ letter might not only help prompt a change to the Australian PI for colchicine, but also a reconsideration of whether a more proactive approach is warranted for updating PI dosing and safety information for orphan drugs.

Nicholas A Buckley · Simone O P Rossi

To the Editor: Since 2008, the Australian Capital Territory’s public acute health care system has successfully been using multiple-parameter and single-parameter track, trigger and response (TTR) systems in parallel for the recognition of and response to clinical deterioration in patients. Jenkins and colleagues correctly identify that there is a general lack of agreement on the use of TTR systems around Australia, although they note that the most commonly used rapid response system is the medical emergency team (MET) alert which is triggered by a single parameter, a vital sign derangement, or a concern for the patient.1 As Jenkins et al suggest, a multiple-parameter TTR system may trigger a response earlier than might occur with MET parameters. In 2007 at Canberra Hospital, a multifaceted before-and-after intervention study of the recognition of and response to patients’ deteriorating conditions found improvements in both patient outcomes and measures of processes of care for patients whose condition was deteriorating.2 The intervention included the installation of a multiple-parameter TTR system, using a modified early warning score3 generated from the degree of derangement of all vital signs and end organ function. Individual vital sign early warning scores were then colour-coded and embedded within newly formatted, human-factors-designed observation charts. Further, before the new system commenced, about 90% of all health care workers (210/234) participated in an education program.4 This program comprised both an e-learning package and a 3-hour, face-to-face, low-fidelity simulation package. It aimed to promote the understanding of the physiological principles of vital signs, and reasons for their measurement and their derangement; it also provided a structure for succinct communication and initial resuscitation. The multiple-parameter TTR system has now been successfully rolled out to all areas of the hospital, including the emergency medical unit, emergency department and medical assessment and planning unit, alongside our MET system. The multiple-parameter TTR system has been a useful tool to engage parent medical teams in reviewing patients at risk of critical illness, and has empowered nurses to call for a MET review, given that the modified early warning score provides further evidence that the patient’s condition is deteriorating. With the use of the systems in parallel and the mandatory training package, MET use has doubled and delays in calling for a MET review have decreased. We would welcome further investigation of the multiple-parameter TTR system that we have adopted, particularly in a multicentre setting.

Imogen A Mitchell · Mary-Ann Kulh · Heather McKay

To the Editor: We would like to congratulate the Central Line Associated Bacteraemia in NSW Intensive Care Units Collaborative for reducing central line-associated bacteraemia (CLAB), and showing that this reduction was associated with compliance with evidence-based aseptic central venous line (CVL) insertion, which included a patient bundle and a clinician bundle, as reported by Burrell and colleagues.1 As part of a quality improvement program in Western Australia, we conducted a collaborative cohort study (unpublished) in two major Perth teaching hospitals with adult intensive care units (ICUs), from April 2007 to September 2008, covering 36 ICU-months and 15 459 catheter-days. Both ICUs implemented the WA Safety and Quality Investment for Reform central line bundle.2 Compliance was monitored by an observer with a checklist. Adherence to all components of the central line bundle was required for compliance to be recorded. This measure was reported monthly. CLAB and catheter-days were monitored by the hospitals’ infection control practitioners. Compliance with the bundle increased from a mean of 10% to greater than 90%. Infection rates declined over the study period from more than six infections per 1000 catheter-days to zero (P = 0.019 for Hospital 1 and P = 0.10 for Hospital 2). In the final 8 ICU-months (4 months in both hospitals), there was no CLAB. The New South Wales study demonstrated the importance of the clinician bundle components over the patient bundle components, which should inform future quality improvement initiatives. We note the comment that the hat, mask and eyewear components of the bundle were unpopular with clinicians. However, there is a risk of recontaminating disinfected skin with aerosolised organisms from the clinician’s hair and upper respiratory tract, whereas eyewear is principally intended to protect the clinician from splash injury and potential blood-borne virus infection. Maximal sterile barrier precautions are endorsed by the 2010 National Health and Medical Research Council guidelines,3 the 2011 Centers for Disease Control and Prevention guidelines,4 and the epic2 study in the National Health Service in England.5

Chantal S Ferguson · Victoria C D’Abrera · Helen J Van Gessel · Dorothy Jones

To the Editor: The article by Ramsey-Stewart and colleagues1 reports a welcome addition to supplemental anatomy education in graduate-entry medical courses in Australia. Increasing medical student numbers are increasing pressure on teaching resources, further propagating the nationally recognised deficiency in anatomy teaching.2,3 In 2010, the University of Queensland Discipline of Surgery developed an extracurricular applied anatomy course to meet the needs of clinical students (Years 3 and 4) with varying foundations in anatomy.4 The course is based on a clinically oriented anatomy education model, using prosected specimens and computer resources, which has been shown to deliver learning outcomes.5 Student representatives were involved in all facets of curriculum development and evaluation. The course was taught by surgeons and provided an overview of whole-body applied anatomy in an interesting and engaging way. As the course had no seed funding, a modest course fee of $90, which was intended to be easily affordable but enough to encourage committed attendance, was charged. Class size was restricted to 44 students, with selections from the 150 applicants (from about 800 students across both years) made on a first-come, first-served basis. Over seven Saturday mornings, the students received 2-hour tutorials from surgeons with expertise in specific fields of regional anatomy. This scheduling minimised disruption for both surgeons and students. Various educational resources, including three-dimensional virtual modelling and potted pathology specimens, were used. Participants completed a short multiple choice test before each week’s tutorial. The course concluded with a wet laboratory session, staffed by surgeons using prosected cadaveric specimens at multiple stations, with a one-to-five surgeon–student ratio. Students completed a post-course exam of collated pre-tutorial multiple choice questions, as well as five-point Likert-scale evaluation forms. The students evaluated the course well (mean Likert score: 4.6 at 4 weeks, 4.8 at 8 weeks). Post-course exam scores demonstrated a small but significant improvement (mean ± SD: pre-course, 43% ± 16.7% v post-course, 50% ± 10.6%; P = 0.004). Scores were correlated with attendance. The course was highly valued by students and surgeons, effectively improved students’ knowledge and satisfied their desire for further anatomy education. The course structure is time-efficient and cost-effective. However, this course, like that of Ramsey-Stewart et al,1 is extracurricular and does not deliver educational benefit to an entire cohort of students. Further development and evaluation are required to extrapolate the benefits of these extracurricular courses into the wider medical curriculum within the constraints of graduate MB BS programs. Our model has expanded to two courses in 2011.

Matthew J Roberts · Bavahuna Manoharan · Marianne Vonau · Russell W Stitz · Owen A Ung

To the Editor: We read with interest the article by Patel and colleagues,1 which suggests a high rate of critical adverse events occurring for medical students undertaking remote placements in the Northern Territory. We note also that there is significant potential for over- or under-reporting because of the incompleteness of useable documentation in their sample. Regardless, the reported figure of one-sixth of students experiencing a “critical incident” during their placement is concerning. In answer to the question in the title of Patel et al’s article — “Safeguard or mollycoddle?” — the answer is surely neither. There is obvious benefit for students in being removed from their personal, cultural, geographical and clinical comfort zones. After all, challenging and evaluating one’s preconceptions and personal boundaries is essential for personal and professional development. However, it is vital that this is done in a safe and well supported manner, such that both the student and the community into which he or she is placed benefit from the experience. As noted by Patel et al, there is evidence from the United Kingdom that structured placements that are regularly evaluated, adequately planned and firmly grounded in clinical ethics are able to maximise the placement experience for both students and communities.2 In our minds, the key to quality in clinical placements is excellent administrative support and clinical supervision that is appropriate for the level of the student. Recently, there has been a concerted push in medical training to encourage students to gain experience in rural and Aboriginal communities. This is generally well received by Australian medical students. In light of increasing student numbers, it is likely that these alternative clinical training environments will see an increase in student traffic in the coming years. The article by Patel et al1 has highlighted that not all experiences in these settings are positive. Due to persisting rural workforce shortages, we are concerned that students who are unwilling and potentially unsuitable to undertake remote placements may be forced to do so through their medical programs or bonded medical places. We strongly urge the providers of placements and those who fund them to critically evaluate their current practices surrounding clinical placement planning and support. Most importantly, adequate supervision, matched to the individual attributes of the student, should be an absolute requisite for any placement.

Andrew D Webster · Robert D Marshall · Lee J Fairhead · Trent Little · Falk Reinholz

To the Editor: The commissioned article by Pirotta, dealing with the ethics of prescribing alternative complementary treatments that may lack an evidence base,1 contains a number of statements which, if the article had been subjected to peer review, might well have finished up on the cutting-room floor. For example, the statement “it is estimated that as little as a quarter of conventional medicine is based on level-1 evidence” is not backed up by the only monograph cited in support of it.2 Whatever relevance a lack of level-1 evidence may have to the practice of dermatology (for which it is claimed), it plays little part in either modern medicine or the revolutionary advances in surgery, few being the result of a systematic review of multiple well controlled randomised trials. Having said that, the reference to complementary or alternative treatments that lack any evidence base as “medicine” gives a misleading legitimacy to practices that may be — and frequently are — based on cultural, historical or spiritual beliefs, or even just plain wacky approaches to healing. Regrettably, Pirotta adds nothing new to the (uncited) definitive 2004 article by Kerridge and McPhee.3 How times have changed. Not only are doctors now expected to have sufficient knowledge of complementary and alternative medicine to be able to advise their patients of therapeutic alternatives, but we may well have reached the stage where a failure to alert patients of such alternative treatment options may constitute negligence at common law. The New South Wales case of McGroder v Maguire4 is instructive. In that case, the plaintiff, a truck driver, had suffered a neck injury in the course of his employment. Despite a lengthy period of treatment, he continued to suffer from tingling in his arm. The defendant, a general practitioner retained by the plaintiff’s employer, although not having examined the patient, nevertheless referred him to a chiropractor. This referral was held to have been negligent, not because of the referral per se, but because of the patient’s condition. This came to light in the evidence given by a neurosurgeon and orthopaedic surgeon at the trial of the action, both of whom agreed that this case was not one for chiropractic manipulation of the plaintiff’s neck and back. Despite subsequent neurosurgery, the plaintiff became totally incapacitated for work. In the result, both the referring GP and the chiropractor were held to be liable in negligence.

Paul Gerber

To the Editor: We read with interest the commentaries by Pirotta and Dwyer on complementary and alternative medicines (CAMs).1,2 This debate has a long history, spanning more than two decades,3 and the pessimism continues to ignore good science.2 Firstly, integrative medicine (IM), which combines alternative and conventional medical practices, is not and never has been synonymous with CAMs. IM is a global paradigm shift that expands the conventional model of medical care with evidence-based laboratory and clinical research. IM embraces the foundations of medicine, such as (i) the critical role of the doctor–patient relationship, (ii) the importance of lifestyle, and (iii) improving the wellbeing and promoting the natural healing potential of people afflicted with disease.4 Secondly, a thinly disguised commentary on the ineffectiveness of CAMs,2 while dismissing a large body of scientific clinical evidence, is broadly misleading. This is significantly remiss, failing to cite the value of prebiotics and probiotics in digestive diseases,5 the effect of omega-3 essential fatty acids on endothelial function,6 the efficacy of acupuncture for some forms of pain,4 mindfulness-based stress reduction and mindfulness-based cognitive therapy for mental health,7 and emerging modalities such as yoga for menopausal symptoms4 and tai chi for fibromyalgia,4 and many more.4 Moreover, such deliberate carelessness serves only to confuse researchers and clinicians, as well as the public. Evidence-based medicine is critical in expanding the medical model of care; of this there can be no doubt. Adhering to biologically plausible mechanisms of action is the key foundation that will always guide scientific evidence, including that for CAMs. As an example, we have recently scientifically challenged the validity of the antioxidant effect to abrogate free radicals that are purported to contribute to the development of chronic diseases.8 Therapies that deviate from the conventional medical model still elicit an unhealthy cynical response2 that hinders the progress of scientific and medical investigations. If Florey and Fleming had adopted such cynicism and dismissed the biologically far-fetched notion of an antimicrobial mould in a Petri dish (Penicillium notatum), they most probably would not have pursued and contributed to the discovery of the antibiotic penicillin. Thus there is no place in science and medicine for the imprimatur of distrust and scepticism that is levelled without respite at novel concepts, even those with scientific plausibility.

Luis Vitetta · Shoshannah L Beck · Samantha Coulson · Avni Sali

To the Editor: I am concerned that the viewpoints by Dwyer1 and Pirotta2 were published without establishing a clear definition of “complementary and alternative medicine” (CAM). The term CAM is not ideal as it groups many non-evidence-based therapies that have little in common, such as iridology and homoeopathy, with more evidence-based complementary therapies such as acupuncture, nutritional medicine, meditation and some herbal medicines that have demonstrated efficacy. To date there is a growing body of research, including Cochrane reviews, to support the use of some complementary therapies (Box). The fact that many complementary therapies have not been tested and subjected to high-quality research does not necessarily mean they do not work.3 For other complementary therapies, there are mixed findings (negative trials balanced by positive trials, as seen in Cochrane reviews), so one needs to ask why the differences in results? Were there differences in dosage, the quality of the substance or method of the therapy tested? Would you argue with patients who find symptomatic relief for troublesome symptoms of menopause from herbs when they are intolerant to hormone replacement therapy, or relief from osteoarthritic pain from complementary medicines and acupuncture if non-steroidal anti-inflammatory medications are contraindicated because of a peptic ulcer? Demand for complementary therapies in Australia is actually coming from consumers. If they found the therapies unhelpful, why would they continue with them? A better term for complementary and alternative medicine is integrative medicine (IM), defined as: the practice of medicine that reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals and disciplines to achieve optimal health and healing.4 The aim of IM is to find common ground and respect for the patients who choose to use complementary therapies and to understand their use. General practitioners have been shown to be very interested in learning about complementary therapies, with one study finding that about 30% of Australian GPs identified themselves as practising IM and most (more than 80%) requesting more education and research in complementary therapies.5 It is important that doctors balance clinical decisions between the risks associated with any therapy, the evidence and the therapeutic clinical outcome (effectiveness) to inform patients appropriately.

Vicki Kotsirilos