Letters

To the Editor: The timely article by Olver and Haines on industry-led versus investigator-led studies in cancer clearly outlines the importance of appropriate trial design.1 However, perhaps one aspect of this critical issue was underemphasised. In cancer trials, overall survival is typically seen as the primary endpoint. In fact, at time of relapse or disease progression, patients are generally treated in a non-uniform manner. In this scenario, treatment is frequently tailored depending on whether the aim of therapy is curative or palliative. Ad-hoc or experimental approaches are used for some patients with relapsed or refractory cancer. Thus, although survival is undoubtedly the most clinically relevant endpoint, the lack of standardisation of treatment at relapse inevitably confounds assessment of the impact of the study drug on survival. Furthermore, for many tumour types, full evaluation of time-to-event outcomes, such as event-free and overall survival, requires prolonged follow-up, resulting in studies taking many years to be completed. For these reasons, biomarkers that accurately serve as early surrogate endpoints to predict for clinical outcome are urgently needed. Yet a striking feature of much industry-led trial design is the paucity of correlative laboratory studies and tissue banking to identify and validate new biomolecular endpoints. Such studies are frequently seen as unnecessary and burdensome. By contrast, although investigator-led laboratory studies of novel biomarkers generate much interest from the clinical and scientific community, their resource and cost implications (chiefly data manager support) prevent many centres from participating. Lucrative company-sponsored trials will always take precedence unless state and/or federal initiatives to support investigator-led studies are enacted. Funding research nurses and data managers to help oncology units conduct non-industry trials that are well designed and incorporate laboratory-based biomolecular research would be an important beginning.

Maher K Gandhi

In reply: We support Gandhi’s contention about the value that can be added to clinical trials by performing correlative laboratory studies. The investigation of biomarkers as potential surrogate endpoints that may indicate efficacy, or lack thereof, earlier than the prolonged time sometimes required to reach a survival endpoint, is one such example. Such studies are often not funded by industry and the importance of funding these, which yield greater clinical benefit, should be recognised by government and non-government agencies. It is possible, but very unlikely, that a survival endpoint may be compromised by the lack of a standardised approach to second-line therapies. We believe that if a new first-line agent is associated with a clinically significant improvement in survival, this will be evident irrespective of subsequent therapies used, which will usually yield inferior results to first-line therapies and will most likely be distributed randomly across the treatment arms. The need for tissue banks as a resource required across trials in all tumours is something that governments could address by funding them as vital clinical research infrastructure. The same applies to data managers for non-industry sponsored trials that are well designed and incorporate laboratory-based research, as Gandhi suggests.

Ian N Olver · Ian E Haines

To the Editor: Parker and Wilkinson raised the issue of medical students who behave inappropriately.1 It is likely that the major way medical students cause distress to others is through deliberate, inappropriate behaviour, representing a deficiency in empathy, rather than through laziness or other mental or social problems. In identifying the problem in these individuals, we need to consider whether the impairment is to the cognitive aspects of empathy — knowing how to behave — or to the emotional aspects — caring about the feelings of other people.2 Inappropriate behaviour can result from differing degrees of impairment in either of these domains, and different courses of action need to be considered for those at the extremes of either type of impairment. An extreme lack of the cognitive components of empathy might be seen in those with developmental disabilities, such as autism spectrum disorders. In these cases, intensive tutoring in professional skills and appropriate career guidance can produce competent and sympathetic doctors.3 At the other extreme, a severe deficiency in the emotional aspects of empathy — not caring about other people’s feelings — may be difficult to correct. Individuals with these psychopathic traits are thought to exist at high levels in many organisations.4 They — especially those with Machiavellian and narcissistic tendencies — may alter their behaviour to become competent medical students. However, their true lack of empathy may become apparent when their careers are secure, and they are in positions of real power. At that stage, they might put patient health and the psychological state of their colleagues at much greater risk. It is likely that some of the most dangerous doctors, such as Harold Shipman in the United Kingdom, represent extreme examples of this pattern. Medical schools need to be certain that any behaviour problems are truly correctable, and consider a thorough personality and cognitive assessment for students who present with inappropriate behaviour, to determine a course of action that will ensure the safety of future patients and colleagues of these students.

Sarah J Abrahamson

To the Editor: Controlled breathing is a fundamental principle of marksmanship. I describe an effect of viral lower respiratory tract infection on small arms training that was unexpectedly prolonged. The patient (myself) had abrupt onset of respiratory infection, 1 day after a marksmanship training session on an electronic firing range. During the session, I obtained satisfactory scores from several firing positions (best score, 66 mm grouping for five shots and 126 mm grouping for 20 shots, at 200 m, prone firing position). The illness progressed rapidly from a non-specific prodrome to a flu-like illness with fever, malaise, muscle aches, lethargy, slowed cognition, cough, sore throat, rhinorrhoea, persistent lacrimation and a 24-hour period of prostration. Recovery began after 48 hours, allowing a return to light work at 72 hours and full working duties by Day 7. On Day 14, during another marksmanship training session, my accuracy was severely decreased. I failed to obtain satisfactory scores in any position because of persistent erratic breathing and occasional involuntary coughing (best score, 235 mm grouping for 20 shots at 200 m). Spirometry later that day showed a reduced peak flow rate (310 L/min) (see Box). Serological tests were negative for IgG and IgA for all respiratory agents assessed. Nasal swabs were positive for parainfluenza virus type 3 by polymerase chain reaction testing. Involuntary coughing, particularly towards the end of the day, and decreased exercise tolerance persisted for a further 2 weeks, by which time peak flow had increased to 500 L/min. A third marksmanship session the week afterwards showed an improvement in scores, but they were still worse than those obtained pre-infection. Notably, grouping deteriorated rapidly after the first series of 20 shots, and could not be regained even after short rests. Replay of the recorded laser beam pattern for the session indicated that the breathing pattern remained erratic, although peak flow had risen further to 550 L/min. In the aftermath of the First World War, the joint head of Germany’s forces, Ludendorff, claimed that the failure of his 1918 spring offensive was ultimately caused by epidemic influenza.1 The epidemic affected German troops later than the allied forces, in June 1918. By July 1918, there were an estimated 500 000 German influenza casualties. Ludendorff’s initial successes were a result of new, highly mobile type infantry tactics — the forerunner of today’s “fire and movement” — which require physical fitness, stealth and accuracy of rifle fire. My case demonstrates that the tactical consequences of a viral lower respiratory infection can last much longer than medically explicit morbidity. Prolonged effects in my case included persistent involuntary cough, loss of exercise tolerance and loss of marksmanship, weeks after the initial acute illness. Ludendorff’s claim may be not so far off the mark. Marksmanship scores* and peak flow rates over time after onset of a respiratory tract infection * Lower scores for shot grouping indicate better marksmanship (shots are more closely grouped).

Timothy J J Inglis

To the Editor: I read with interest the research article by O’Connor and colleagues, which concluded that the medical and retrieval costs of road crashes in rural and remote northern Queensland represent “a considerable economic burden”.1 Although the authors noted that the broader Rural and Remote Road Safety Study aimed to also gain an understanding of the social costs of such crashes, they focused on the monetary costs in this report. As we all know, road crashes not only cost money but have enormous personal impact, in both the short and long term, on the patients and their families. This impact is likely to be even greater for patients from rural and remote areas who are unable to be cared for in their local hospital. Remember that for almost all patients transferred, there are families who must also find their way to, and temporary accommodation (sometimes for months) in, an unfamiliar large town or city. Close family members, in addition to the patient, also suffer loss of income, disruption of schooling, and loss of personal network support due to the geographic dislocation. Thank you to the authors of this study, which reinforces the desperate need to continue to improve local health services in rural and remote Australia, including “more efficient trauma management”,1 to contain costs and to lessen patient and family suffering.

Susan M Gorton

In reply: We can only agree with Gorton about the high level of costs to families and communities caused by road trauma. While our report attempted to provide estimates of the immediate, direct costs to the medical system,1 we were well aware of the additional costs to families, particularly those from rural and remote areas, as they attempted to support their injured family member. These costs, unfortunately, are difficult to quantify, and have a long-term impact on families and communities. Although our study was able to estimate some of the costs associated with road trauma, there is a need for prospective studies with specially formulated costing tools to capture the costs more fully. An associated study describing the impact of road trauma on the work of general practitioners in rural and remote areas2 outlined the problems that GPs have in managing chronic vehicle-related trauma without access to specialist rehabilitation services. Improving local health services may reduce some costs to families, but many of the patients retrieved from rural road crashes initially require specialist care in tertiary-level facilities. Changing the behaviour of drivers who take risks on roads will also reduce the costs of road trauma. Unfortunately, this is a difficult process.

Teresa M O’Connor · Heather A Hanks · Mark S Elcock · Richard C Turner · P Craig Veitch

To the Editor: More than 1000 sunscreen products are marketed in Australia, and an increasing proportion (about one-third) incorporate engineered nanoparticles (ENPs). Defined as manufactured particles having one or more dimensions less than 100 nm (0.00001 cm), ENPs exploit the altered chemical reactivity and other changes that reduction to nanosize elicits. ENPs in sunscreen, such as titanium dioxide (TiO2) and zinc oxides, constitute effective broad-spectrum ultraviolet radiation (UVR) blocking agents with enhanced cosmetic transparency. The Australian Therapeutic Goods Administration (TGA), in approving such products, has stated that “there is no evidence that sunscreens containing these materials pose any risk to the people using them”.1 Similarly, authors of a recent article (written in collaboration with representatives of a cosmetic company) interpret the evidence as confirming that ENPs do not penetrate below the stratum corneum, or only in small amounts, producing limited cellular toxicity.2 Information on sunscreen packaging is not required to disclose the presence of ENPs. Yet, when TiO2 nanoparticles are incorporated into human cells in vitro, mobilisation of electrons by absorption of ultraviolet A (UVA) light produces reactive oxygen species and causes DNA damage (strand breakage and base modification). In fact, TiO2 has been used in this way to kill cancer cells in vitro.3 In sunscreens and cosmetic preparations, TiO2 is often coated to reduce this photocatalytic activity because over 90% of ambient UVR is UVA. However, evidence has now emerged that TiO2 in uncoated anatase form has been added to a marketed but as yet undivulged Australian sunscreen — in this form, TiO2 is capable of producing damaging photocatalytic free-radical reactions on particular steel roofing materials.4 Likewise, zinc oxide ENPs manufactured for use in sunscreens are potent biocides and subject to disposal restrictions in most countries. Despite the TGA’s stance, existing research does not comprehensively ensure the safety of all ENPs in sunscreens, particularly ENPs less than 40 nm in size applied long term to human skin that is immature, aged, diseased, damaged, hairy or covering flexural creases.5 The non-government organisation Friends of the Earth has compiled a list of sunscreens available in Australia that are claimed by the manufacturers to be free of nanoparticles.6 A New South Wales Government committee has recommended that, for regulatory purposes, ENPs be considered new chemical entities that require increased safety data.7 Policymakers should increase funding for objective research in this area (such as that by Macquarie University and the flagship project in nanotechnology of the CSIRO [Commonwealth Science and Industry Research Organisation]). Until such safety data are available, the TGA should apply the “precautionary principle”5 and, at a minimum, increase packaging information about nanoparticles in sunscreens.

Thomas A Faunce

Sed quis custodiet ipsos custodes? (Who guards the guardians?) To the Editor: Adler and Constantinou raised a concern about the ageing doctor1 that also worried me when I was practising as an anaesthetist. The same concern was raised recently in the Australian and New Zealand College of Anaesthetists Bulletin.2 In anaesthesia, decisions and actions have to be made in seconds and minutes, rather than days and weeks, and maintenance of standards is very important. Doctors practise largely in isolation, and may not be aware of their standard failing against the general standard. Operating theatres offer both an opportunity to observe the practice of others and a conduit for information on colleagues — nursing and medical. I used this opportunity in private and public practice by asking younger colleagues, one in each, to be my “buddy”, as in diving safety. They were asked to keep watch for any rumour of my declining standards and to report it to me. We would then discuss what to do: retrain or retire. The latter became more of an option the older I grew. This strategy opened up pathways. One was that the buddy was given the authority to approach me on the topic. Another was that I was open to the idea that my ability could diminish, while a third was that the hostility, so often seen in this setting, was abolished. I would rather be tapped on the shoulder by a sympathetic colleague than a medical board, a hostile coroner or a vindictive prosecution lawyer. In the end, there was no tap on the shoulder, and I went because I had had an enjoyable and rewarding career and could afford to retire. This allowed succession planning in both areas, public and private, and a younger colleague could embark on a similar path.

David G Fenwick

To the Editor: We read with interest the recent editorial by Van Der Weyden on the issue of doctor displacement.1 We agree completely that a transparent and evidence-based approach to health care roles is essential. In proposing a pilot program of physician assistants (PAs) in South Australia to examine the potential of “physician extenders”, we broadly used the model applied to the introduction of new therapies in medicine, including new drugs: Evidence of an unmet need; Evidence of safety and efficacy in another setting; A monitored pilot/trial in practice; Re-evaluation after a defined period with a defined process; and An emphasis on any ongoing utilisation being a consistent and national process. This last point is noted in the Australian and New Zealand College of Anaesthetists’ submission to the National Health and Hospitals Reform Commission.2 We emphasised the need for any proposed future clinical role for PAs to be defined, followed by identification of the required knowledge base, training and education requirements, and certification. Not all new health care roles have followed such a pathway, and this provides potential challenges for ensuring quality, safety, consistency and “trademark definition” (widespread understanding of the role). In the case of PAs, it was evident at a recent International Forum for Physician Assistant Education in the United States that the definition of the term “physician assistant” varies greatly internationally, potentially confusing future debate on this topic in Australia. Hence, to develop a robust Australian model, any proposals for ongoing use and training of PAs would have to be discussed at a national level.

Guy L Ludbrook · Guy J Maddern

To the Editor: The Journal’s Editor is a man of words and we love him for it, but, as Lord Tennyson said: “For words, like Nature, half reveal and half conceal the Soul within” (In memoriam A. H. H., 1850). So what does his Christmas issue editorial1 really reveal about our man of words? He has unfortunately biased the debate about physician assistants and other alternative health care providers with his editorial’s very title: “Doctor displacement”. Doctors will not be displaced — liberated, perhaps, to concentrate on things that interest them, where their advanced skills can be best used and where they can make the most impact. This is not (nor should it be) about maintaining the status quo. The debate should be about how to provide health care to patients and the community, ensuring that they can get appropriate advice from well trained professionals when and where they require it. Most health services are now provided by teams — no longer is it ethical to promote the idea of an autonomous practitioner, be it nurse or doctor. The great strength of the physician assistant is that it is a “delegated model”, dependent on the doctor and not, as the editorial suggests, able to practise independently. Physician assistants will never be able to practise independently; they will always have to practise under supervision and within the scope of practice of their supervisor. Nowhere in Van Der Weyden’s editorial is the issue of preventive health, as an important physician assistant or other health professional role, raised, nor the fact that health professionals might use teleconsulting to link across disciplines and geographical areas. These are aspects that could change workforce requirements dramatically. Australia currently spends a minor fraction (less than 5%) of its $90 billion health budget on trying to prevent illness.2 We must use our health dollars more wisely and effectively. Also absent from the editorial is mention of the current global shortage of 4.5 million health workers. On this point, the MJA should look to the Lancet to see how it has consistently run a global agenda on health services and workforce, pointing out our responsibilities to low- and middle-income countries.3 The world is divided into those with and those without effective health care. Opinions on proposed changes to health care split into those who say “why?” and those who say “why not?” Editor, you have always appeared to us to be in the latter group. Please don’t disappoint us now by becoming a nay-sayer. We want to see this Journal promoting a health system that is patient-focused and health professional-friendly, and not one that just maintains the status quo.

Peter M Brooks · Charles A Mitchell

In reply: I appreciate the comments of Brooks and Mitchell on the importance of words to editors — they are, after all, their tools of trade. Indeed, this is no more so than in the titles of editorials, wherein their succinctness must not only encapsulate the tone and theme of the text but, having captured the readers’ attention, induce them to read on. It seems, however, that the title of my recent editorial “Doctor displacement: a political agenda or a health care imperative?”1 has caused disquiet and prompted the accusation of “bias”. And the offending word? “Displacement”. The Concise Oxford Dictionary defines the verb “displace” as: “shift from its accustomed place”, “remove from office” and “take the place of; oust”. Given the substance of the editorial, it was my intention that all these connotations were relevant in the context of this many-layered debate. In essence, the editorial focused on the urgent need for the profession to address, or at least debate, the increased instances of “task transfer” or “role substitution” occasioned by the escalating numbers of nurse practitioners and physician assistants. Despite Brooks and Mitchell proffering the conventional justification of this recent phenomenon as being “teamwork”, history tells us that this may well be academic double-speak. One precedent was the protracted tussle some 300 years ago between organised medicine and apothecaries, who were to eventually evolve into the progenitors of general practitioners.2 More recently, there have been well documented instances of physician assistants establishing independent practices in the United States.3 One could say that the very title of my editorial seems to have mesmerised Brooks and Mitchell, who have fixated on its seeming bias, ignoring the editorial’s subsequent exploration of current workforce issues in the delivery of quality health care and the urgent plea for the profession to have an evidence-driven debate. On the other hand, it is easy to appreciate their sensitivity to the phrase “doctor displacement”, given their ongoing commitment to the University of Queensland’s postgraduate physician assistant training program.

Martin B Van Der Weyden

To the Editor: Isoniazid is used extensively for the treatment of active and latent tuberculosis (TB). It is generally well tolerated by children, and hypersensitivity reactions resulting in skin rash and requiring cessation of treatment are rarely reported in this age group.1,2 We report a case of isoniazid hypersensitivity in a 21-month-old boy potentially exposed to TB in a childcare setting. He was one of over 80 children screened after contact with a childcare worker who showed a positive smear result. His initial tuberculin skin test (TST) was negative and, in line with New South Wales guidelines,3 he was commenced on isoniazid 150 mg daily (10mg/kg/day) while awaiting a repeat TST. After 3 days of treatment, he developed a small number of round vesicular lesions on his tongue. They were associated with mild discomfort but his appetite was not affected. There were three small maculopapular lesions on his legs and back that reportedly looked like mosquito bites before blistering. The child remained afebrile and was systemically well. The family general practitioner considered that this presentation was possibly an allergic reaction and isoniazid was discontinued. Population health staff were consulted, and the risks and benefits of further isoniazid treatment were discussed with paediatric TB specialists. It was recommended that, after the rash had resolved, isoniazid be reintroduced at half the dosage and with close supervision. Two days after isoniazid 75 mg daily was recommenced, the rash recurred. The child’s mother described lesions appearing as “burns all over his tongue” and reported further sores around his lips and six welt-like lesions on his legs. Isoniazid was immediately discontinued, the skin lesions resolved within 5 days and no further antituberculous therapy was administered. His repeat TST 12 weeks after the initial test was negative and he remains well. No other potential triggers for a hypersensitivity reaction were identified. In particular, no other medications were administered during this period or for the week before commencing isoniazid. According to his mother, the child had experienced a similar reaction within 1 hour of a single dose of ibuprofen when he was 8 months old. Several tongue blisters were accompanied by a generalised fine maculopapular rash lasting several days. We concluded that the child most likely had a hypersensitivity reaction to isoniazid that required discontinuation of treatment. We reported this to the Therapeutic Goods Administration, which advised that it had received seven other reports since 1991 of suspected hypersensitivity, but none were for children under 10 years of age.

Tony D Merritt · Peter D Massey

To the Editor: Accidental asphyxia in very young children is an ongoing problem caused by hazardous sleeping environments and toddlers’ inability to understand dangers or to physically extricate themselves once entrapped. Two common problems involve children becoming wedged between mattresses and cot sides or walls, and hanging from clothing caught on projections inside cots.1 Autopsy in such cases requires careful death scene evaluation to prevent confusion with sudden infant death syndrome and to identify any evidence of inflicted injury, if present. National legislation requiring both new and second-hand cots to meet Australian safety standards has reduced the numbers of unsafe cots on the market. I report a case of another continuing, albeit less common, circumstance that is also resulting in lethal outcomes for toddlers — about one child dies every 1–2 years in Australia in this manner.2 A healthy 13-month-old boy was placed in his cot next to a window with blinds from which a cord was hanging. A loop of the cord measuring about 10 cm was hanging inside the cot. When checked later, the boy was found unresponsive, hanging from the cord. Resuscitation attempts were to no avail. At autopsy, a parchmented ligature mark was present around the neck, with facial and conjunctival petechiae. There were no other injuries or significant illnesses present. Death was therefore attributed to accidental hanging. (Further information on this case is available in the Finding of Inquest.3) Prevention of such tragic fatalities requires ongoing public awareness campaigns, using pamphlets such as the Australian Government’s blind and curtain cords safety alert brochure,2 to advise parents and child carers to keep cots and furniture that can be climbed on away from windows that have curtain or blind cords, to use cleats and cord wind-ups to keep cords at least 1.6 m above the floor, to cut loops, and to keep cords that must be looped under tension with tie-down devices. A safety tassel is also available that clips the two ends of a cord together but that easily separates when put under pressure.4 In addition, national legislation similar to that currently enacted in New South Wales and other states would provide uniform guidelines for managing these devices that would include warning labels and written safety information for parents.4

Roger W Byard

To the Editor: There is danger of a perception developing that, to ensure patient confidentiality, quality assurance (QA) activities in health care should be regarded as research. The Australian Law Reform Commission (ALRC) has delivered proposals for the review of the federal Privacy Act 1988 (Cwlth) that may lead to all but the most basic monitoring of health care activities being characterised as research.1 Recommendation 65–3 emphasises that “research” should include “the compilation or analysis of statistics” and the ALRC also stated that “some funding, management, planning, monitoring, improvement and evaluation activities also may be characterised as research”. This drives the possibility for policy interpretation of QA activities into the realm of research necessitating ethics approval and/or informed consent, rather than retaining the current level of exemption. Australian governments are crying out for increased transparency to improve safety, but labelling QA activities as formal research could seriously compromise and retard patient safety efforts. A key to enabling optimal patient safety is the implementation of evidence by practitioners competent in judgement, skill and knowledge within an environment characterised by leadership and adequate resources (for example, through morbidity and mortality meetings and clinical audits).2 Implementing clinical monitoring (eg, antibiotic use, so essential to optimal outcomes and to minimising antibiotic resistance) requires audit of patients’ files. Improvement in current practices requires scientific, planned, data-driven study with ongoing review, which includes elements that could easily be characterised as research. If these activities and resultant quality improvement efforts are now regarded as research, their progress may be impeded. It should be considered unethical not to act on established evidence. It would be dangerous to label as research surveillance and QA activities that are designed to ensure implementation of such evidence, even if they fall within the broad definition of research. Patient privacy and confidentiality must be managed within a transparent regulatory framework without impeding safety mechanisms with research frameworks that would inevitably lead to delays and increased costs, as well as seriously discouraging staff from implementing them. These effects are well documented overseas where the enactment of similar privacy rules relating to the use of patient information has resulted in detrimental unintended consequences.3,4 Work undertaken to discover new and better evidence needs to be regarded as research, not work to ensure that established evidence-based practice is properly implemented. Herein lies the difference. Although the National Health and Medical Research Council (NHMRC) provides advisory guidelines,5,6 the proposed privacy (health information) regulations to be developed by the Office of the Privacy Commissioner1 will provide the legal basis for the use of health information. The public benefit of QA activities with appropriate privacy management and regulation that avoids designation as research requires strenuous championing during development of the regulations to ensure continued improvement in patient safety.

Anthony P Morton · Susan E Smith · Peter R Croll · R Michael Whitby

To the Editor: In the 3 November 2008 issue of the Journal, Millar recommends against routine thromboprophylaxis in medical patients.1 The evidence base for clinical decision making regarding thromboprophylaxis in medical patients remains limited. Although its overall benefit may be low, the absolute benefit to the community is significant. As up to 40% of cases of venous thromboembolism (VTE) occur in patients recently hospitalised for medical illness,2-3 there is a significant burden of disease that justifies prophylaxis in patients at high risk of VTE. The challenge is to identify medical patients at greatest risk of VTE, and to provide appropriate pharmacological prophylaxis, but to avoid using prophylaxis in patients at lower risk of VTE. Millar states that aspirin is as effective as heparin, with reference to the Pulmonary Embolism Prevention (PEP) trial.4 However, the PEP trial compared aspirin with placebo, and many participants also received heparin — it did not compare aspirin with heparin. Participants were undergoing surgery for hip fracture, and none were medical patients. A reduction in the endpoint of fatal pulmonary embolus (PE) is difficult to demonstrate in trials where imaging is used to detect disease at an early stage. This prompts treatment of asymptomatic deep vein thrombosis and modifies the natural history, leading to low reported PE rates. Rather than recommend for or against routine thromboprophylaxis in medical patients, we advise that patients should have a VTE risk assessment and that appropriate prophylaxis should be given according to evidence-based guidelines such as those of the American College of Chest Physicians5 and the International Consensus Statement6 (which we have attempted to summarise and condense into a practical, pocket-sized booklet7).

John P Fletcher · Donald MacLellan · Harry Gibbs · Geoff Matthews

To the Editor: “What is the health service for?”1 In essence, this is a question of definition and ownership. What is the definition of quality health care and who decides how it is defined? Who are the recipients of health services, the funders, those who stand to lose or benefit from the way in which health care is delivered? The answer is citizens. When we define quality, we are making a value judgement; we are saying what it is about health care that we consider important and worthy of achieving. In a democratic society, we expect that the values of citizens will be reflected in the definition of health care quality. The United States Institute of Medicine initiative, “Crossing the quality chasm”, emphasises “patient-centered(ness)” and care “customized according to patient needs and values” as system attributes for delivering quality health care to individuals.2 Yet, a broader perspective is suggested in the following statement on the objectives of health care systems from the World Health Organization: The objective of good health itself is really twofold: the best attainable average level — goodness — and the smallest feasible differences among individuals and groups — fairness. Goodness means a health system responding well to what people expect of it; fairness means it responds equally well to everyone, without discrimination.3 Implicit in both definitions is knowing what people expect, need and want from their health service. What do Australians expect, need and want from their health service at an individual, local and national level? How can we engage citizens effectively to answer these questions? We need a process of informed public consultation, a process that is constructive, efficient and representative, to guide the vision and values that form the basis of our health system. Menadue highlights the Canadian Romanow-led Royal Commission as an example of community engagement.1 A similar initiative underlies the United Kingdom’s “Our NHS [National Health Service] our future”, where a process involving consumer consultation has been employed at all levels of health care reform and in the development of an “NHS Constitution”.4 Mooney suggests “citizens’ juries” and a “National Citizens’ Summit”.5 Whatever our Australian national solution, as key stakeholders in the health system, as its patients and its health workforce, citizens need to be given a genuine opportunity to influence and contribute to the future direction of Australian health care.

Amanda E James

To the Editor: Wills and Coory emphasise maternal smoking as a risk factor for preterm birth and low birthweight, with exaggerated effects apparent in Indigenous women.1 They suggest that governments have a responsibility to ensure that interventions are offered to help women quit. Unfortunately, there are adverse effects of smoking cessation that mitigate the gains of cessation and introduce a caveat to that otherwise laudable motive. It has been shown that young women who cease smoking almost always gain significant weight.2 The fall in smoking rates in women over the past 20 years appears to have been in inverse proportion to the rise in rates of obesity in pregnancy, suggesting a possible relationship. The adverse maternal and fetal effects of overweight and obesity in pregnancy have been confirmed in numerous studies,3-5 and equal or exceed those of smoking. Typical odds ratios (ORs) from the literature3-6 are shown below. Maternal overweight (body mass index [BMI], 25–30 kg/m2) and obesity (BMI, > 30 kg/m2) are associated with significant increases in pre-eclampsia (OR for overweight, 1.8; OR for obese, 3.0), gestational diabetes (1.8; 3.2), macrosomia (1.6; 2.4), shoulder dystocia (2.9 for obese), obstructed labour, caesarean delivery (1.5; 2.0), postpartum haemorrhage (1.2; 1.5), wound infection (1.3; 2.2), venous thromboembolism (1.3; 2.8) and maternal death. Further, overweight and obesity are also associated with increased rates of infertility, fetal abnormality (OR, 1.3–3.5), miscarriage (1.2–3.0), stillbirth (1.5; 2.0), admission to neonatal intensive care (1.2; 1.4) and neonatal death (1.6–2.7 for obese). In addition, the adverse effects of excessive weight gain during pregnancy are very similar to those detailed above.7 The long-term effects on the offspring of women who were obese in pregnancy (increased rates of obesity, diabetes and components of the metabolic syndrome) are well documented,8 and at least equal in severity to the consequences for the children of smokers. What then should we do? Should we condone smoking during pregnancy? No one would agree. Ideally, women should never start smoking, or they should give up without gaining weight, but these are elusive aims. At the very least, the conscientious practitioner must provide weight-control counselling, referral to a dietitian and an exercise program lest the gains of smoking cessation be overwhelmed by the losses accompanying excess maternal weight gain, overweight and obesity in pregnancy.

Barry N J Walters

To the Editor: Macneil and colleagues1 present evidence of how inadequate resourcing of acute kidney stone care for public patients in New South Wales is compromising their surgical outcomes compared with private patients. In our experience, the same difference exists elsewhere in Australia. Macneil and colleagues show how poorly planned, under-resourced and badly coordinated acute surgical services lead directly to adverse surgical outcomes. All too often, a lack of appropriate modern lasertripsy equipment, staff trained to operate it, or provision of adequate emergency theatre time leaves public patients languishing with a double-J stent (inserted as a temporising measure) for an extended period. Not treating stones definitively at presentation (in cases where surgery is appropriate) adds unnecessary morbidity and necessitates readmission, further compounding the inefficiencies of an already overstretched public system. Given such important findings, it is disappointing that the Journal chose only to publish Macneil’s study as a letter. The conclusions of this study should provide an impetus for addressing proper coordination and resourcing of surgical services in the public system throughout Australia.

Robert J Davies · R Denby Steele · John Kourambas

To the Editor: Access to timely, definitive management of kidney stones after initial short-term management in the New South Wales public hospital system has long been a source of frustration for urological surgeons and their patients. These patients will, for the most part, ultimately receive treatment that is successful. Although this may be reflected in final outcome data, the financial and personal costs associated with unacceptable delays between staged treatment episodes is unlikely to be documented. The assessment of kidney stone management by the Greater Metropolitan Clinical Taskforce reported by Macneil and colleagues highlights the types of problems that are endemic in NSW,1 and is based on strong input from clinicians who are not under pressure to manipulate data to give the most favourable assessment of the state of health care delivery. It has broader implications regarding appropriate and timely management of staged treatment of other acute conditions that require surgery — in particular, the treatment of urinary retention due to benign prostatic obstruction. Until now, the saving grace for the NSW Department of Health with respect to these issues has been a lack of resources and will to capture this information. Such information creates embarrassment regarding an inadequately resourced and organised approach to the staged care of acute conditions requiring surgery. Inadequate basic access to kidney stone treatment in the public hospital system is just the “tip of the iceberg”, and is one of many examples of the substantial divide that exists between access to optimal health care in public versus private hospital systems. The real state of health in NSW has been spared from exposure by a lack of resources and will to define the true extent of problems. It seems unlikely that the problems that have been exposed in the public hospital system are isolated to NSW.

Henry H Woo · Michael P Wines

To the Editor: Critics of the proposal to legalise trade in kidneys have pointed out the low rates of renal transplantation in Australia compared with the United States,1 where the trade in organs is also illegal. However, it is unclear if the lower rate of renal transplantation in Australia is a result of a shortfall in transplants from living or deceased donors. First, I ranked renal transplantation rates in 2005 in US states and from Australia using the numbers of transplants from deceased and living donors from the United States Renal Data System (Beth Forrest, Coordinating Center, US Renal Data System, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md, personal communication), the Australia and New Zealand Dialysis and Transplant Registry,2 and populations from the US Census Bureau.3 In 2005, there were 12.1 per million population renal transplants from living donors in Australia. All of the states of the US except Oklahoma had higher rates of renal transplantation from the living, and the rate in Minnesota was four times higher. In contrast, the rate of renal transplantation from deceased donors in Australia was 18.6 per million population, which was higher than 24 American states and lower that 26 states and the District of Columbia. Some US states had twice the Australian rate of kidney donation from the deceased. I then used multiple linear regression to examine associations between rates of renal transplants from the deceased and rates of homicide, suicide and motor vehicle accident deaths in US states.4 Rates of renal transplantation from living donors were included as a covariable to control for differing degrees of development in US state transplant services. Homicide rates were associated with rates of transplants from the deceased (R = 0.607, R2 = 0.386; Box), but deaths from suicide and motor vehicle accidents were not. Hence, the higher rate of renal transplantation from deceased donors in the US appears to be the result of greater availability of organs from homicide victims. The high mortality and morbidity associated with endstage renal failure, despite renal dialysis treatment, suggests a need for new approaches to increasing the availability of donor kidneys. Assumed consent for organ donation might increase donation rates from the deceased, but this has been resisted in both Australia and the US on the grounds that failure to opt out might only indicate lack of forethought and not consent. While Australia continues with an opt-in system for deceased donation, measures to encourage live donation might have more realistic prospects of success than attempts to increase the rate of renal transplantation from the deceased.

Matthew M Large

To the Editor: A 60-year-old Hispanic woman, who had lived in the United States for 10 years, presented with a 1-day history of altered mental status. Physical examination revealed ascites and enlarged right axillary lymph nodes. Magnetic resonance imaging (MRI) of the brain showed multiple intracranial lesions (Box, A). Computed tomography of the chest and abdomen showed massive adenopathy in the right axilla, multiple nodules in upper lung fields, ascites and retroperitoneal adenopathy. Her cancer antigen (CA) 125 level was 1469 U/mL (reference range, 0–35 U/mL); CA27.29 and CA19-9 levels were within the upper limit of the normal ranges. She was initially thought to have metastatic cancer of unknown primary site. However, a right axillary node biopsy revealed necrotising granulomas and no malignancy; an acid-fast bacteria (AFB) stain was negative. Ultrasound-guided retroperitoneal lymph node biopsy showed necrotising granulomas and no malignancy; an AFB stain was positive. We began investigations for disseminated tuberculosis (TB). A QuantiFERON-TB Gold test (Cellestis, Valencia, Calif, USA) and sputum and right axillary node cultures were positive for Mycobacterium tuberculosis; peritoneal and cerebrospinal fluid cultures were negative. Polymerase chain reaction (PCR) of samples of peritoneal fluid and from bronchoalveolar lavage was negative for M. tuberculosis DNA, but a sample from the retroperitoneal lymph node tested positive. The patient was started on four-drug therapy for TB and her condition progressively improved. Follow-up MRI of the brain 5 months later showed a decreased size of all intracranial lesions (Box, B), and her CA125 level was 84 U/mL. Peritoneal TB can mimic advanced ovarian cancer because of similarities in clinical signs and symptoms, such as ascites, abdominal pain and elevated CA125 levels.1 The association of peritoneal TB with high CA125 levels was first described in 1987.2 The positive predictive value of CA125 levels to detect malignancy is estimated at 60%, rising to 98% in postmenopausal women.3-4 In most reported cases of peritoneal TB, CA125 levels were below 500 U/mL; rarely, levels up to 1200 U/mL have been seen.1-4 Culture is of limited clinical usefulness, as results take up to 6 weeks. Although microscopy is rapid, cheap and highly specific, its sensitivity has been shown to be as low as 31% for extrapulmonary TB.5 PCR is of limited value in diagnosing peritoneal TB. Detecting M. tuberculosis DNA by PCR in ascitic fluid poses many challenges — differences in technique, contamination with other bacteria, and the variable number of acid-fast bacilli in samples have been shown to influence its reliability.4-5 Negative results from microscopy, culture and PCR should not distract from a diagnosis of TB. In the face of a growing international incidence of TB, it is important to consider this transmissible and treatable disease in the context of abdominal symptomatology, ascites and raised serum CA125 levels — especially in ethnic groups in which TB prevalence is high. Misdiagnosis or delayed diagnosis can lead to infertility, premature menopause and death. Magnetic resonance (MR) imaging of the brain before and after treatment A: B rain MR image showing multiple intracranial lesions involving the left cerebellum, left occipital lobe, left parietal lobe and corpus callosum. B: MR image of the brain 5 months post-treatment, showing a decrease in the size of all intracranial lesions.

Riad O El Fakih · Bassem M Chehab · Rami A Mortada · Maha Assi

To the Editor: Keogh and Clifton’s call for salt reduction in the food supply1 comes when the National Heart Foundation is telling doctors who treat patients with hypertension that they should “recommend low-salt and reduced-salt foods as part of a healthy eating pattern”.2 Humans evolved while eating foods that (with rare exceptions) are low in salt — fresh fruit, vegetables and nuts, supplemented sometimes with fresh meat, poultry or fish — and these foods are still abundant. Using cooking methods that conserve flavour and any of about 300 herbs and spices, they make delicious meals that are low in fat, saturated fat, sugar and salt. Keogh and Clifton’s point is that we need more processed foods that are low in salt. This could be brought about if all doctors prescribed low-salt diets for their patients with hypertension.2 The food industry could hardly fail to respond to an unprecedented demand from the 3.7 million hypertensive Australians who need low-salt foods. Low-salt foods (sodium ≤ 120 mg/100 g) are easy to prescribe, requiring neither a diet nor a dietitian. In Britain, “traffic light” labels identify them at a glance, with green lights for salt. Australian consumers wishing to identify them have to check the mandatory sodium figure in the nutrition information panel provided on all processed food packages for a value of 120 mg/100 g or less. Further information to help consumers identify low-salt foods is available on the SaltMatters website (http://www.saltmatters.org), and a comprehensive handbook for practitioners and motivated patients has also been published.3 A low-salt diet is also particularly important for patients with Ménière’s disorder, because sodium excretion < 50 mmol/day is “more effective and less troublesome than diuretics” for controlling their vertigo.4 This level of sodium excretion occurs when all meals are low in salt.5 The National Heart Foundation’s marginally easier limit of 65 mmol/day allows room for a small mistake or a reduced-salt food, but practitioners must remember that the “combination of diuretic treatment and low dietary salt intake may result in unacceptable volume depletion and hyponatraemia”.6 The National Heart Foundation recommends 24-hour urine sample collections for monitoring dietary compliance (see “Measuring Salt Intake” at the SaltMatters website).

Trevor C Beard

To the Editor: We read with great interest Drini and colleagues’ recent report of hepatosplenic T-cell lymphoma (HSTCL) associated with inflammatory bowel disease. The occurrence of this rare lymphoma is partly driving a move away from the use of combination thiopurine and anti-tumour necrosis factor alpha therapy. It is important to recognise that risk of HSTCL is not only associated with exposure to thiopurine drugs with or without infliximab. It is associated with immunocompromise in general, and also occurs de novo. Explaining relative risks to patients is never easy and needs to be balanced with the need for treatment in properly selected patients. Contrary to a comment by Drini and colleagues, HSTCL has been reported in association with exposure to adalimumab, another anti-tumour necrosis factor alpha agent.2 Two of these cases occurred in patients with prior exposure to thiopurines and infliximab, and the third occurred in a patient with rheumatoid arthritis who was not exposed to thiopurine or infliximab. There has been a recent spate of reports of HSTCL in patients with inflammatory bowel disease treated with immunomodulator therapy, but most HSTCL appears to occur in patients without exposure to immunosuppressants.3 Also, although cases predominantly occur in young men (under 22 years), HSTCL is not limited to the paediatric age group.3,4 The presentation also occurs in females, including during pregnancy. More generally, in patients with inflammatory bowel disease, treatment with thiopurines appears to increase the risk of lymphoma two- to fourfold.5 Assuming a fourfold increase in risk, this translates into one additional lymphoma per year for every 4357 patients treated with thiopurines at age 20–29 years.5 This should be compared with the lifetime attributable risk of death from any cancer due to a single abdominal computed tomography scan performed at the age of 20, which is in the order of 1 : 2000.6 Currently, it is difficult to completely disentangle the many different factors — including patient age; severity, duration and course of disease;7 type of immunosuppression; and exposure to radiation — when considering the risk of lymphoma in inflammatory bowel disease. However, in many patients with severe disease, this risk appears to be outweighed by the benefits of adequate medical control.

Daniel C Burger · Timothy H J Florin

To the Editor: The article by Outram and Nair on peer physical examination1 misses the point that consent by medical students for physical examination by their peers can never be freely given. It always contains elements of coercion. Ethics committees usually do not allow medical students to enter clinical trials run by staff, who at some point may be their assessors, because there may be subtle duress to participate. Even if consent for peer physical examination is sought by staff who will be neither assessors nor tutors of these students, non-consenting students are immediately apparent to their colleagues, creating peer pressure to participate. The emotionally vulnerable are the most likely to accede to this and the most likely to be distressed. It is unsafe to rely on all staff seeking consent and behaving appropriately at all times. In one Australian medical school, students were told that they all had to “bring their swimmers” to wear so that they could be examined by other students. The statement that peer physical examination “has high acceptability”1 is not supported by the cited literature, and it is not clear to whom it is highly acceptable. There are good arguments for learning physical examination skills on the healthy. If young bodies are needed for this, universities are full of students from other faculties, and medical schools are not so poor they cannot pay the small amounts of money valued by these students for their participation.

John E Marley

In reply: Marley states that consent for peer physical examination “always contains elements of coercion”. It could be argued that this applies equally to medical practice and research, as one can never be 100% sure that participants have not felt some coercion. The ethical imperative is to balance the issues, to gain the best outcome. The article by Nair and myself reviewed the literature, reported additional research in the main area where difficulties had been noted (culturally and linguistically diverse students) and, on the basis of that evidence, suggested best practice.1 Contrary to Marley’s assertion, the articles we reviewed do support high levels of acceptability: 98%,2 97%,3 and 94%,4 respectively. Marley’s statement that emotionally vulnerable students are most likely to accede to peer physical examination and then be distressed may sound correct, but there is no evidence for this. In our experience, medical students are assertive, including those from the minority groups surveyed. Although the cost of direct payment to non-medical university students acting as “models” may be relatively small, the process of recruitment, training and processing by overstretched academic staff has significant opportunity costs. Additionally, medical students acting as models have the opportunity to experience the patient’s perspective. We acknowledge some criticisms of the practice of peer physical examination. However, it is currently widely used and will continue to be. The intent of our article was to draw attention to unforeseen difficulties and to improve practice.

Suzanne Outram