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Issues

Volume 192 Issue 5

1 March 2010

From the editor’s desk

1 March 2010 Free

The Stanford 25

* Yeomans N. Foreword 1. In: Talley NJ, O’Connor S. Clinical examination: a systematic guide to physical diagnosis. 4th ed. Sydney: MacLennan & Petty, 2001. “Clinical examination is something of an arcane art. It is a badge that defines a doctor. To an important extent, the process of history taking and physical examination is also able to be used as a vehicle to transmit that the doctor cares and wants to help ...”* Not only does the physical examination establish a connection between doctors and patients, it is part of a continuum linking them to clinicians of the past — clinicians whose names are enshrined in physical signs they were the first to describe. But physical examination is under threat. Medical practitioners of the 21st century work in an increasingly time-poor environment. Gone are the days when clinicians were respected for the skill they brought to the bedside. The emphasis these days is on how many tests can be performed! This threat to the physical examination recently prompted clinicians at the Stanford School of Medicine to develop the “Stanford 25” — a list of 25 technique-dependent, physical diagnostic manoeuvres that are now mandatory for trainees to learn. These include such basics as fundoscopic examination, pupillary reflexes, examination of the thyroid, liver and spleen, and elucidation of ankle reflexes in a recumbent patient. All this takes me back some 30 years, when, as a research fellow at Duke University Medical Center in North Carolina, one of my tasks was to teach a semester devoted to clinical examination. Only then did I realise how well Australian physicians are grounded in the art of clinical examination throughout our undergraduate and postgraduate years. The skills imparted to us were light-years ahead of those learned by our counterparts in the United States. Even today, it is easy to distinguish the US from the Australian graduate by the latter’s confidence and expertise in the skills of clinical examination. Let us hope that this continues, and we need never resort to protocols such as the Stanford 25.

Martin B Van Der Weyden

1 March 2010 Free

In This Issue

Paying for excess Overweight and obesity are costing Australia much more than was previously thought, say Colagiuri and colleagues, whose estimate of total direct costs in 2005 is a whopping $21 billion. The estimate is derived from 5-year follow-up data on participants in the Australian Diabetes, Obesity and Lifestyle study (AusDiab), and includes direct health care costs such as hospitalisations, prescriptions and ambulatory services, direct non-health care costs such as transport to hospital and support services, and government subsidies such as pensions and benefits. AusDiab used both body mass index and waist circumference to define overweight and obesity, and participants in both these categories incurred substantially higher costs than those of normal weight. The authors say their bottom-up approach of extrapolating from individual costs should provide more robust estimates than previous studies, which calculated costs by looking at obesity-related health problems and were unable to look at the effect of overweight (→ The cost of overweight and obesity in Australia). Dire diabetes warning Australian experts have joined their international colleagues in calling for nations across the globe to commit themselves to preventing diabetic kidney disease. As World Kidney Day approaches (11 March 2010), Atkins and Zimmet remind us that diabetes is now the major cause of end-stage kidney disease worldwide and that rapidly increasing rates of diabetes mean the problem is set to escalate, especially in developing countries. Turning this around will require a massive diabetes prevention effort, awareness of and screening for diabetic kidney disease, access to effective management, and continued resources for the development of new therapies (→ Diabetic kidney disease: act now or pay later). Cough & come again Although a very common presenting symptom in clinical practice, cough can be distressing and diagnostically confusing when it becomes chronic. The CICADA (Cough in Children and Adults: Diagnosis and Assessment) guidelines have been several years in the making by an impressive multidisciplinary group of experts. They appear in summary form, with clear recommendations for both adults and children, in (→ CICADA: Cough in Children and Adults: Diagnosis and Assessment. Australian Cough Guidelines summary statement). Poached or pushed? The problem of less developed countries losing doctors and other health workers via migration to more developed countries has led the World Health Organization to challenge countries such as Australia to consider the global effects of their international recruitment strategies. While Australia needs to fulfil its obligations in this regard, Arnold and Lewinsohn’s survey of South African doctors working in Australia demonstrates that, for doctors from some developing countries, recruitment may play a relatively minor role. Of the 469 doctors contacted, 434 (93%) indicated that their desire to leave their country was a much stronger driver than Australia’s attempts to attract them. Reasons for migration changed over time, with opposition to apartheid predominating before 1990, and the level of violent crime in South Africa being the main “push factor” in later years (→ Motives for migration of South African doctors to Australia since 1948). National trachoma snapshot After a 30-year gap in national data collection, the 2008 National Indigenous Eye Health Survey indicates that blinding trachoma remains a problem in many remote Indigenous communities. Taylor and colleagues examined 1694 Indigenous children and 1189 Indigenous adults from 30 communities, finding an overall rate of follicular trachomatous inflammation of 3.8% among children (ranging from 0.6% in major cities to 7.3% in very remote areas). Half the communities in very remote areas had endemic trachoma rates (> 5%). Among adults, 15.7% had trachomatous scarring, 1.4% had trichiasis, and 0.3% had corneal opacity. Early last year, the federal government announced a $58 million funding package for Indigenous eye and ear disease, with a focus on eradicating trachoma in Australia, which is the only developed country in which the disease is still endemic (→ The prevalence of trachoma in Australia: the National Indigenous Eye Health Survey). Harmonising ethics review Late last year, Hicks and colleagues published an article road-testing the new New South Wales centralised ethics review system for multicentre trials. Although the time to ethics approval was reduced compared with the old system, the total time taken was as long as ever owing to the need for site-specific governance approval. In this issue’s Letters (→ A case study evaluation of ethics review systems for multicentre clinical trials), several other research groups add to the call for a more efficient process, with high hopes for the ongoing Harmonisation of Multi-centre Ethical Review (HoMER) initiative. For researchers in Indigenous health, centralisation of ethics review for multisite studies will not negate the need for local community approval and engagement. The National Indigenous Eye Health Survey (mentioned above and reported in “The prevalence of trachoma in Australia: the National Indigenous Eye Health Survey” of this issue) was such a study. In “Ethics review of multisite studies: the difficult case of community-based Indigenous health research”, Studdert and colleagues describe its complex ethics approval process, and put forward some ideas for future streamlining. Another time . . . another place You dig your grave with your teeth. Proverb

Ruth Armstrong

Editorials

Environmental health 1 March 2010 Free

Clinical-quality registries: their role in quality improvement

Registries can provide sound data needed by clinicians and organisations to improve patient safety and quality of care In June 2009, the National Health and Hospitals Reform Commission released its report proposing an agenda to transform the Australian health system.1 A critical element of this agenda is improved monitoring of service delivery and outcomes of care. Clinical-quality registries are an important development in monitoring and benchmarking quality of clinical care. Registries systematically and uniformly collect information from people who undergo a procedure, are diagnosed with a disease or use a health care resource. They are particularly appropriate for monitoring and benchmarking processes and outcomes of care where there is known variation and where poor performance results in high additional cost (eg, renal transplantation) or poor quality of life. Before outcomes are benchmarked, data must be statistically adjusted to isolate quality of care from prognostic factors that are beyond the influence of clinicians. Variables such as age and clinical comorbidities are typically included in risk-adjustment models. Registries are ongoing data-collection exercises, and the validity of their results relies on near-complete inclusion of all eligible patients. To achieve this goal, use of an “opt-out” consent process is recommended. Where registries have used “opt-in” consent, recruitment rates have been as low as one in six of those eligible, making data unreliable for benchmarking, and rendering the registry ineffective.2 Where an opt-out approach has been used in the United States, recruitment rates as high as 97% have been achieved,3 with even higher rates in Australia (< 1% opt-out in the Australian Orthopaedic Association [AOA] National Joint Replacement Registry and Victorian State Trauma Registry). Clinical-quality registries aim to improve quality of care through benchmarking clinical outcomes and stimulating competition in achieving best practice. The registry set up by the Danish Lung Cancer Group exemplifies what can be achieved. Feedback of indicators of high-quality care derived from registry data to those delivering care has been largely responsible for improvement in 30-day, 1-year and 2-year survival rates for people with lung cancer of 1.6%, 8% and 10%, respectively.4 In addition to providing information on safety and efficacy of treatment, data from registries can also be used to determine whether patients have timely access to care,5 and whether care is delivered in line with best practice and evidence-based guidelines.4,6 Process measures are frequently built into clinical-quality registries to detect variations in clinical approach and explore differences in outcomes. For example, stroke registries established in Canada routinely collect data to assess speed and appropriateness of thrombolytic treatment.7 Collection and feedback of data must be underpinned by an effective central governance structure for the registry, with strong clinical leadership, and a regulatory framework providing incentives for quality improvement and proactive approaches for managing poor performance. There must also be strong local clinical leaders who are accountable for ensuring that registry outcomes drive quality improvement. The impact of poor registry governance was highlighted in an inquiry into cardiac surgery at the Bristol Royal Infirmary in the United Kingdom.8 Since the inquiry, improvements have been made to ensure that findings from the Central Cardiac Audit Database are provided to surgeons and are also publicly reported. Clinical-quality registries can improve safety and reduce costs. Findings of the AOA National Joint Replacement Registry show a decline in the rate of hip and knee revision surgery over a 4-year period from 14.8% to 11.1% and from 10.4% to 7.9%, respectively, with an associated annual cost saving of $44.6 million.9 Since its inception in 2001, the Victorian State Trauma Registry has shown a 30% reduction in mortality among trauma victims.10 These improvements may be attributed at least in part to a monitoring system that provides ongoing feedback to contributing sites, detailing their risk-adjusted outcomes relative to those of peer organisations, and to the institution of remedial processes to manage outliers. International momentum is gathering to develop new clinical registries as quality-improvement measures. For example, Sweden has established a network of more than 70 quality registries and has made available resources to assist in establishing new registries.11 In the UK, a national directory of registries has been established to enhance the usefulness of registries in monitoring quality of care.12,13 The US Agency for Healthcare Research and Quality has produced a guide to the design, operation, analysis and evaluation of patient registries.14 In Australia, the document Operating principles and technical standards for Australian clinical quality registries has been developed under the auspices of the Australian Commission on Safety and Quality in Health Care and is now being evaluated.15 Australia has 28 clinical registries, which continuously collect patient-level health-related data, including outcomes, and operate across many health care sites.16 In Australia, new registries are required in a range of areas where improved quality of care is likely to lead to significant improvements in safety and outcomes. A national registry of cardiac procedures and devices has been widely advocated.17 New registries should be established in strong clinical research environments with access to people skilled in clinical epidemiology, biostatistics and clinical data management. Registry custodians must ensure that their registries collect complete data from as many eligible patients as possible; give accurate and timely feedback to clinicians and organisations; and have well-functioning governance structures. They must ensure that lessons are shared among contributors and that data are continuously used to drive improvement in practice. With high-quality data from clinical registries, there is a strong potential to engage clinicians more intensely in quality improvement activities.

John J McNeil FRACP, MSc, PhD · Sue M Evans PhD · Niall P Johnson PhD · Peter A Cameron MB BS, FACEM, MD

Cardiovascular diseases 1 March 2010 Free

Troponin measurement and the new assays: how low can we go?

More sensitive assays may provide more information, but we are not yet sure of the clinical relevance of this information The introduction of troponin measurement into clinical practice in Australia 10 years ago led rapidly to its widespread use as the marker of choice for diagnosis and risk stratification of patients with acute coronary syndrome (ACS). However, opportunities remain for improving risk assessment in “troponin-negative” patients, many of whom will have adverse events. This has led to the development of new, improved assays that are able to measure down to much lower concentrations than before (10–100-fold lower than current assays), and that increase the detection of acute myocardial infarction, as shown in two recent cohort studies.1,2 The improved analytical performance of these assays may be particularly useful in the early period following the onset of chest pain. These two studies indicated improved diagnostic accuracy of samples taken from patients with chest pain, both at the time of presentation to the emergency department (ED), and within 3 hours of symptom onset.1,2 This improved early sensitivity may lead to significant benefits in ruling out ACS, and in risk assessment, diagnosis and management of patients with ACS, although neither of these studies provided corroboration with clinical outcome. The development of these new “highly sensitive” assays for cardiac troponin raises many questions about their clinical application, including the degree of analytical precision, the medicolegal definition of myocardial infarction, earlier detection and improved management of patients with ACS, as well as the interpretation of elevated cardiac troponin levels in other clinical situations. The current accepted international definition of myocardial infarction — the “universal definition of myocardial infarction”3 — requires a rise or fall in the level of cardiac biomarkers (preferably troponin) with at least one value above 99th percentile of the upper reference limit, along with at least one clinical indicator (symptoms of ischaemia, new ischaemic changes or new Q waves on electrocardiogram, new imaging evidence of loss of viable myocardium or a new regional wall motion abnormality). The use of assays that do not have optimal precision (coeffficient of variation [CV] < 10% at the decision level) is not recommended, although, a variety of the older, less precise assays are still in clinical use. New, highly sensitive (hs) assays have the recommended degree of analytical precision, and the first (Roche hsTnT, Roche Diagnostics) has been launched while others are in preparation. Their use would lead to an increase in the diagnosis of myocardial infarction. Measuring low levels of troponin introduces an additional confounder — that of significant biological variability4 — which would require an increase in the traditionally accepted 20% serial change of troponin level over baseline values that is required to meet the definition of myocardial infarction.5 The application of cardiac troponin measurement in risk stratification of patients presenting with ACS has been strongly supported by clinical data. Measurable cardiac troponin levels in these patients, even concentrations below that corresponding to the recommended assay precision (CV < 10%), are associated with adverse clinical outcomes. In addition, aggressive management has been shown to improve clinical outcome in these high-risk patients. It is possible that the hs assays will improve the identification of high-risk patients who benefit from aggressive management, but this will require clinical validation. From an ED perspective, the new assays present the possibility of identifying patients at very low risk of 7-day or 30-day adverse events at a much earlier stage. Two hs troponin assays at least 3 hours apart, or one assay taken at least 6 hours after symptom onset may be accurate in ruling out myocardial infarction in the ED, but the evidence for this approach is so far limited.2 This should allow for more immediate decision making in relation to proceeding to further testing (such as an exercise stress test or stress echocardiography) and discharge from the ED, and could significantly decrease overnight admissions of patients with possible cardiac chest pain. The use of any biomarker assay in managing chest pain or possible ACS should always be done in conjunction with a full clinical assessment to ensure appropriate risk stratification. The other common clinical question is how to interpret cardiac troponin levels in patients without clinical features of ACS. There have been several reports suggesting that normal healthy people without cardiac disease may have very low, but detectable levels of troponin present at all times.6,7 This raises the intriguing possibility of cardiomyocyte turnover and renewal.8 Low levels of cardiac troponin have also been identified, and have been shown to be correlated with structural heart disease, diabetes mellitus and chronic kidney disease in a small percentage of the general population.9 Screening of asymptomatic elderly men for serum troponin predicted the risk of future cardiac events.10 Although troponin release has traditionally been thought to be caused by cardiomyocyte necrosis, recent information suggests that troponin may be released after ischaemia without necrosis in patients undergoing stress testing.11 A 10-fold increase in low-level troponin concentration has also been identified in athletes after marathon running.7 Elevated troponin levels are not uncommon in patients in intensive care units, and possible causes include supply/demand ischaemia and alterations in myocyte membrane permeability or leakage. The likelihood of ACS in these patients is low in the absence of usual symptoms or evidence of acute ischaemia or infarction. Cardiac troponin levels may also be elevated by non-coronary causes including myocarditis, aortic dissection, Tako-tsubo syndrome, pulmonary embolism, cardiac trauma, sepsis, tachycardia, severe heart failure, and “false positives” that include heterophile antibodies and analytical imprecision. All elevations in cardiac troponin concentrations, and particularly in low-level measurements, should be interpreted in the context of the pretest probability of ACS, as well as possible non-coronary causes of troponin release. In conclusion, our understanding and interpretation of troponin concentration and use of the new highly sensitive assays continue to evolve. This may offer us greatly enhanced opportunities for early diagnosis, risk assessment and improved management, but their widespread use will require clinical validation. More than ever before, however, there is a clinical imperative not to immediately equate detectable troponin concentration with ACS, but to interpret each result in its clinical context.

Con N Aroney MD, FRACP, FCSANZ · Peter E Hickman MB BS, PhD, FRCPA · Hans G Schneider MD, FRACP, FRCPA · Jillian R Tate BSc(Hons), MSc · Martin Than FACEM, FCEM

Research

Indigenous health 1 March 2010 Free

The prevalence of trachoma in Australia: the National Indigenous Eye Health Survey

Objective: To determine the prevalence of trachoma among Indigenous Australians.Design, setting and participants: A national, stratified, random cluster sample survey of Indigenous children (5–15 years) and adults (≥ 40 years) in 30 communities across Australia. Data collection was undertaken in 2008.Main outcome measures: Results based on a standardised protocol that included trachoma grading and double grading of photographs of the tarsus.Results: 1694 Indigenous children and 1189 Indigenous adults were examined. Recruitment rates were 84% for children and 72% for adults. The overall rate of follicular trachomatous inflammation among children was 3.8%, ranging from 0.6% in major cities to 7.3% in very remote areas; 50% of communities in very remote areas had endemic rates (> 5%). Trachomatous scarring (TS) occurred among 15.7% of adults, trachomatous trichiasis (TT) among 1.4% and corneal opacity (CO) among 0.3%. TS was found in all regions and TT in all except major cities and inner regional areas. The highest community rates for TS were 58.3%; for TT, 14.6%; and for CO, 3.3%.Conclusion: Blinding endemic trachoma remains a major public health problem in many Aboriginal and Torres Strait Islander communities. Although active trachoma is predominantly seen in very remote communities, scarring and blinding sequelae occur among Indigenous people across the country. The Australian Government’s recent commitment to eliminate blinding trachoma is welcomed and much needed.

Hugh R Taylor AC, MD, FRANZCO · Sarah S Fox BA · Jing Xie PhD · Ross A Dunn BAppSci(App Chem), GradDip(BIT) · Anna-Lena M R Arnold BSc · Jill E Keeffe OAM, PhD

Cardiovascular diseases 1 March 2010 Free

Cardiovascular risk perception and evidence–practice gaps in Australian general practice (the AusHEART study)

Objective: To examine the perception and management of cardiovascular disease (CVD) risk in Australian primary care.Design, setting and participants: The Australian Hypertension and Absolute Risk Study (AusHEART) was a nationally representative, cluster-stratified, cross-sectional survey of 322 general practitioners. Each GP was asked to collect data on CVD risk factors and their management in 15–20 consecutive patients aged ≥ 55 years who presented between April and June 2008, and to estimate each patient’s absolute risk of a cardiovascular event in the next 5 years.Main outcome measures: Estimated 5-year risk of a cardiovascular event, proportion of patients receiving appropriate treatment.Results: Among 5293 patients, 29% (1548) had established CVD. A further 22% (1145), when categorised according to the 2009 National Vascular Disease Prevention Alliance guideline, to 42% (2211), when categorised according to National Heart Foundation (NHF) 2004 guideline, had a high (≥ 15%) 5-year risk of a cardiovascular event. Of the 1548 patients with established CVD, 50% were prescribed a combination of a blood pressure (BP)-lowering medication, a statin and an antiplatelet agent, and 9% were prescribed a BP-lowering medication and a statin but not an antiplatelet agent. Among high-risk patients without established CVD, categorised using NHF 2004 adjustments, 34% were prescribed a combination of a BP-lowering medication and a statin. GPs estimated 60% of patients with established CVD as having a risk of less than 15%. The GPs’ estimates of risk among patients without established CVD agreed with the centrally calculated estimate (according to the NHF 2004 guideline) in 48% of instances (κ = 0.21).Conclusions: These data confirm substantial undertreatment of patients who are at high risk of a cardiovascular event. We recommend that GPs assess absolute risk for older patients and ensure that high-risk patients receive evidence-based pharmacotherapy.

Emma L Heeley BSc(Hons), MSc, PhD · David P Peiris MB BS, MIPH, FRACGP · Anushka A Patel MB BS, PhD, FRACP · Alan Cass MB BS, FRACP, PhD · Andrew Weekes BMedSci, BM BS · Claire Morgan BPhysio · Craig S Anderson MB BS, PhD, FRACP · John P Chalmers MD, PhD, FRACP

Health care

Environmental health 1 March 2010 Free

The cost of overweight and obesity in Australia

Objective: To assess and compare health care costs for normal-weight, overweight and obese Australians.Design, setting and participants: Analysis of 5-year follow-up data from the Australian Diabetes, Obesity and Lifestyle study, collected in 2004–2005. Data were available for 6140 participants aged ≥ 25 years at baseline.Main outcome measures: Direct health care cost, direct non-health care cost and government subsidies associated with overweight and obesity, defined by both body mass index (BMI) and waist circumference (WC).Results: The annual total direct cost (health care and non-health care) per person increased from $1472 (95% CI, $1204–$1740) for those of normal weight to $2788 (95% CI, $2542–$3035) for the obese, however defined (by BMI, WC or both). In 2005, the total direct cost for Australians aged ≥ 30 years was $6.5 billion (95% CI, $5.8–$7.3 billion) for overweight and $14.5 billion (95% CI, $13.2–$15.7 billion) for obesity. The total excess annual direct cost due to overweight and obesity (above the cost for normal-weight individuals) was $10.7 billion. Overweight and obese individuals also received $35.6 billion (95% CI, $33.4–$38.0 billion) in government subsidies. Comparing costs by weight change since 1999–2000, those who remained obese in 2004–2005 had the highest annual total direct cost. Cost was lower in overweight or obese people who lost weight or reduced WC compared with those who progressed to becoming, or remained, obese.Conclusion: The total annual direct cost of overweight and obesity in Australia in 2005 was $21 billion, substantially higher than previous estimates. There is financial incentive at both individual and societal levels for overweight and obese people to lose weight and/or reduce WC.

Stephen Colagiuri MB BS, FRACP · Crystal M Y Lee BMedSc(Hons), MIPH, PhD · Ruth Colagiuri BEd, GradCertHlthPol · Dianna Magliano BAppSci(Hons), MPH, PhD · Jonathan E Shaw MD, MRCP, FRACP · Paul Z Zimmet AO, MD, PhD, FRACP · Ian D Caterson MB BS, PhD, FRACP

Position statement

Immune system diseases 1 March 2010 Free

CICADA: Cough in Children and Adults: Diagnosis and Assessment. Australian Cough Guidelines summary statement

Cough is a common and distressing symptom that results in significant health care costs from medical consultations and medication use. Cough is a reflex activity with elements of voluntary control that forms part of the somatosensory system involving visceral sensation, a reflex motor response and associated behavioural responses. At the initial assessment for chronic cough, the clinician should elicit any alarm symptoms that might indicate a serious underlying disease and identify whether there is a specific disease present that is associated with chronic cough. If the examination, chest x-ray and spirometry are normal, the most common diagnoses in ADULTS are asthma, rhinitis or gastro-oesophageal reflux disease (GORD). The most common diagnoses in CHILDREN are asthma and protracted bronchitis. Management of chronic cough involves addressing the common issues of environmental exposures and patient or parental concerns, then instituting specific therapy. In ADULTS, conditions that are associated with removable causes or respond well to specific treatment include protracted bacterial bronchitis, angiotensin-converting enzyme inhibitor use, asthma, GORD, obstructive sleep apnoea and eosinophilic bronchitis. In CHILDREN, diagnoses that are associated with removable causes or respond well to treatment are exposure to environmental tobacco smoke, protracted bronchitis, asthma, motor tic, habit and psychogenic cough. In ADULTS, refractory cough that persists after therapy is managed by empirical inhaled corticosteroid therapy and speech pathology techniques.

Peter G Gibson MB BS, FRACP · Anne B Chang FRACP, MPHTM, PhD · Nicholas J Glasgow FRACGP, MD, FAChPM · Peter W Holmes MB BS, FCCP, FRACP · Peter Katelaris MB BS, MD, FRACP · Andrew S Kemp MB BS, FRACP, PhD · Louis I Landau AO, MD, FRACP · Stuart Mazzone PhD · Peter Newcombe DipT, BEd, PhD · Peter Van Asperen MB BS, MD, FRACP · Anne E Vertigan BAppSc(SpPath), MBA, PhD

Endocrinology 1 March 2010 Free

Diabetic kidney disease: act now or pay later

The 21st century has the most diabetogenic environment in human history with the number of people with diabetes worldwide increasing to 380 million by 2025. The fastest rate of increase will be in developing countries. Diabetes is now the major cause of end-stage kidney disease globally; 20%–40% of people on dialysis are diabetic. In Australia, the number of people with type 2 diabetes starting dialysis increased fivefold between 1993 and 2007. We must act now at local, national and international levels to prevent type 2 diabetes; screen for early diabetic kidney disease; increase public awareness of kidney disease; treat with medications proven to reduce kidney disease progression; and promote research into and trialling of new therapies. The problem is global yet requires local action. World Kidney Day on 11 March 2010 is a time to intensify action on diabetic kidney disease and to continue to do so until this huge but largely preventable health burden is controlled.

Robert C Atkins MSc, DSc, FRACP · Paul Z Zimmet PhD, MD, FRACP

Research enterprise

Indigenous health 1 March 2010 Free

Ethics review of multisite studies: the difficult case of community-based Indigenous health research

Researchers have longstanding concerns about the logistical and administrative burdens posed by ethics review of multisite studies involving human participants. Centralised ethics review, in which approval by one committee has authority across multiple sites, is widely touted as a strategy for streamlining the process. The Harmonisation of Multi-centre Ethical Review (HoMER) project is currently developing such a system for Australia. It is unclear how centralised review will work for multisite Indigenous health research, where the views of local stakeholders are important and community consultation is mandatory. Our recent experience in conducting the National Indigenous Eye Health Survey (NIEHS) shows how elaborate the current ethics approval and community consultation processes can be, and points to several lessons and ideas to guide pending reforms.

David M Studdert LLB, ScD, MPH · Tamara M Vu LLB · Sarah S Fox BA · Ian P Anderson MB BS, PhD · Jill E Keeffe PhD · Hugh R Taylor MB BS, MD

Notable cases

Hematologic diseases 1 March 2010 Free

Hyperhaemolysis in sickle cell disease — an unusual and potentially life-threatening complication

As sickle cell disease is increasing in Australia, paediatricians and other health care providers need to be aware of the broad range of complications that can occur in this condition. Although the complications of splenic sequestration and chest crises are well recognised, the infrequent but equally dramatic complication of hyperhaemolysis is less well appreciated. Here, we report a case of hyperhaemolysis in a Victorian paediatric patient.11 Clinical recordA 12-year-old boy with sickle cell disease (homozygous haemoglobin S) presented in July 2006 with abdominal pain and fever — symptoms of a vaso-occlusive crisis. His usual baseline haemoglobin level ranged from 65 g/L to 75 g/L. He was thriving, but had a history of numerous vaso-occlusive crises. His past management included repeated transfusions with Rhesus and Kell phenotypically matched, leukocyte-depleted (LD) red cells. During this admission, he was managed with intravenous (IV) fluids, IV analgesia, antibiotics and a transfusion of 1 unit of phenoytpically matched, crossmatch compatible, LD red cells. His pain gradually resolved and he was discharged home. Twenty-four hours after discharge (7 days after the transfusion), he re-presented with marked lethargy, jaundice, tachycardia, and no increase in splenic size. His haemoglobin level was 45 g/L and reticulocyte count was increased, at 444 × 109/L (reference range, 20–200 × 109/L). He received a transfusion of a further 2 units of red cells (about 500 mL). However, he remained pale after the transfusion and his haemoglobin level had further decreased to 39 g/L. He also developed profuse haemoglobinuria. Based on his estimated blood volume of 2350 mL, the total transfusion of 750 mL during the two admissions would equate to an increase in haemoglobin of 55 g/L, so the observed drop in haemoglobin level was consistent with haemolysis of both recipient and donor red cells. No red cell alloantibodies or autoantibodies were detected. A presumptive diagnosis of sickle cell hyperhaemolysis syndrome was made. Further transfusions were avoided, and the patient was treated with IV immunoglobulin (IVIG) (1 g/kg) and high-dose IV steroids (methylprednisolone, 20 mg/kg/day). IV mannitol and hyperhydration were commenced to avoid free haemoglobinaemia-associated renal damage. The patient recovered after 1 week and was discharged, with a haemoglobin level of 71 g/L. Six months later, the patient experienced a further episode of marked haemolysis that occurred after a red cell transfusion for vaso-occlusive crisis. He presented to hospital 5 days after the transfusion with a 48-hour history of increasing pain, increased jaundice and discoloured urine. His bilirubin level was 129 μmol/L (reference range, < 10 μmol/L) (unconjugated, 125 μmol/L; conjugated, 4 μmol/L), which was greater than a previous measurement of 77 μmol/L. Again, no red cell alloantibodies or autoantibodies were detected, and his reticulocyte count was elevated, at 303 × 109/L. His haemoglobin level continued to fall after admission, reaching 24 g/L after 24 hours. He was managed with further IVIG and high-dose steroids. In view of his ongoing marked, symptomatic anaemia after 3 days of this treatment, he was transfused with 250 mL of phenotypically matched red cells, without complication, and was discharged 2 days later with a haemoglobin level of 71 g/L. He did not re-present with further haemolysis. Follow-up is ongoing, with management as clinically indicated. This was a prolonged and dramatic event for the child and his family. Placing him on a regular transfusion program was discussed, but the risks of repeated transfusions and the possibility, although small, of another hyperhaemolysis event were considered to outweigh the benefits of maintaining a higher haemoglobin level in a child who was thriving. If a regular transfusion program were to be considered again in the future, it would be prudent to assess the risks and benefits of exchange transfusion. Treatment with erythropoietin was also considered but deemed unnecessary at this time. Pretransfusion steroid treatment was considered an appropriate addition to the future management of this patient. DiscussionSickle cell disease is increasing in incidence in Australia due to immigration patterns involving increasing numbers of people from regions where the disease is common, such as Africa.1 Although hyperhaemolysis in sickle cell disease has been recognised for more than 20 years, this case highlights it as an uncommon but potentially life-threatening complication, involving destruction of both donor and recipient red cells after red cell transfusion.2-5 Haemolysis can be rapid and profound. Onset is usually within 7 days after transfusion and is characterised by severe intravascular haemolysis, haemoglobinuria, and anaemia to levels of haemoglobin lower than pretransfusion levels. Reticulocytopenia may be present. Hyperhaemolysis has also been reported in patients with β thalassaemia and myelofibrosis.6,7 Recurrent hyperhaemolysis is unusual in children, with few available data pertaining to this phenomenon in the paediatric population. The information provided by patients in whom recurrence occurs is particularly valuable. Human leukocyte antigen antibodies were not tested in the patient described here, nor were his haemoglobin S levels followed during these episodes. Measurement of these parameters in other affected patients would add to the body of data and knowledge on hyperhaemolysis. The exact mechanisms responsible for hyperhaemolysis are not fully understood. High-performance liquid chromatography analysis of urine in a patient with haemoglobinuria after red cell tranfusion demonstrates both donor and recipient haemoglobin.8 In typical haemolytic transfusion reactions, alloimmune mechanisms are responsible, with the development of red cell antibodies in the patient against antigens present on donor red cells. The antigens most commonly implicated are those of the Rhesus, Kell, Kidd, Duffy and MNSs blood group systems. Haemolytic reactions due to alloimmunisation are associated with haemolysis of donor red cells only, and laboratory testing usually leads to identification of the causative red cell antibodies. Suggested mechanisms for hyperhaemolysis include cytokine-mediated haemolysis or uncontrolled macrophage activation.9-11 Recommended treatment of hyperhaemolysis includes avoidance of transfusion where possible and immune modulation with steroids and IVIG.3,5,8 The mechanism of action of steroids and immunoglobulin has not been fully elucidated, but these treatments have been demonstrated to be effective in a number of patients. Repeated exposure to red cells after recovery may lead to recurrence of hyperhaemolysis, as seen in this case. Erythropoietin may be used in an attempt to reduce the need for further exposure to transfused red cells.3 Prompt referral for expert management is essential. Hyperhaemolysis is an uncommon but potentially fatal complication of sickle cell disease. Recognition of this unusual complication is important for medical staff who manage patients with sickle cell disease in Australia.

Ian C Stokes BSc(Hons), BM BS · Peter A Downie MB BS, FRACP · Erica M Wood MB BS, FRACP, FRCPA · Donald K Bowden MB BD, FRACP · Paul T Monagle MB BS, FRACP, FRCPA · Chris D Barnes MB BS, FRACP, FRCPA

Viewpoint

Fit for the future — a regional governance structure for a new age

Australia’s health care system is at a crossroads. It is recognised that the fragmentation of health services, largely caused by the split between Commonwealth and state government funding responsibilities, is undermining patient care. The National Health and Hospitals Reform Commission (NHHRC) has advanced two models of health-system governance to redress this situation — neither incorporating the regional approach so prominent in submissions to the NHHRC and included in Option B of the NHHRC interim report. A regional governance framework such as that described in this paper could keep faith with the importance widely given to local engagement during the consultation process; sit neatly within the NHHRC’s Healthy Australia Accord option; make regions responsible for funding allocation and service delivery; eliminate major weaknesses in our current system; and provide stability to the system at a time of significant reform.

Claire L Jackson MB BS, FRACGP, MD · Caroline Nicholson MBA, GradDipPhty, GAICD · Eugene P McAteer MBA, BSSc, GAICD

The profession

Motives for migration of South African doctors to Australia since 1948

Objective: To determine why more than 2000 doctors have migrated from South Africa to Australia since 1948.Design, setting and participants: South African-trained doctors living in Australia and the spouses or adult children of deceased practitioners who had emigrated from South Africa were contacted by email between August 2008 and February 2009. The sample of doctors was gathered and expanded by an email “snowball” technique and through advertising in alumni and professional journals and newsletters. A questionnaire was emailed to 653 contacts.Main outcome measure: Primary reason given for migration.Results: Responses were received from 469 of the 653 email contacts (72%), from a population of about 2200 South African doctors in Australia. Of the 469 respondents, 434 (93%) had been motivated to emigrate by a wish to leave South Africa, rather than by Australian inducements. The primary reason for emigration before 1990 was opposition to apartheid (142/205 [69%]); the primary reason for emigration after 1990 was the level of violent crime (including “safety” issues) (116/264 [44%]).Conclusion: Most South African doctors who migrated to Australia were impelled to emigrate by South African issues, rather than attracted by Australia.

Peter C Arnold BSc, MB BCh BA · David E Lewinsohn DipAppChem, GDipDP, PGDipPDM

Letters

National registration legislative proposals need more work and more time

To the Editor: Having been closely involved with the initiation of the practitioner impairment and performance processes of the New South Wales Medical Board, I appreciate Breen’s generous remarks about the efficiency and fairness of the existing medical boards’ processes.1 In addition to wholeheartedly endorsing his concerns about the proposed medical regulation legislation, I consider that the profession should not lose sight of the origin of these “reforms” — the Productivity Commission’s report on the health workforce.2 This government “workforce” initiative is far removed from the concerns of any registration body — namely, “standards”. Our medical boards have hitherto rightly divorced themselves from workforce considerations. The profession should be concerned that an inquiry into the health workforce has resulted in a national standards body. This mismatch suggests a hidden agenda behind the new legislation to be adopted by all states and territories. Can our governments, Labor or Coalition, be trusted not to combine their powers over the new registration authority and over Medicare to exercise ham-fisted controls over doctors? Australians have already suffered the disastrous Wooldridge reduction in Medicare provider numbers in 19963 — resulting in today’s scramble to train more doctors. Breen says that most doctors have not opposed the proposed scheme.1 As one of the minority who do, I claim that the Emperor has no clothes. The devil is not in the detail, but in the principles. Breen correctly identifies the only valid, but weak, argument for national registration — that “the existing regulatory system [is] somewhat inefficient in terms of interstate mobility”.1 Australia’s health care problems relate primarily to lack of coordination between governments,2 not to standards. There is little regarding standards that could not have been ironed out by the state and territory medical boards and the Australian Medical Council. We are about to witness a horrendous waste of public money by governments whose primary goal, I suspect, is control over our profession — over our numbers, over our education, over our registration, over our postgraduate training, over our standards, and over the nature and location of our eventual practice of medicine. Today’s and tomorrow’s doctors have my sympathies.

Peter C Arnold

Ethics 1 March 2010 Free

A case study evaluation of ethics review systems for multicentre clinical trials

To the Editor: The evaluation by Hicks and colleagues of the centralised ethics review system in New South Wales1 codifies important additional time delays facing researchers conducting multicentre trials that include NSW. These delays have direct financial consequences that continue to limit the viability (especially when staff are on time-limited grants) and productivity of multisite research in Australia, without adding value to the ethical conduct of the research.2 There is also inconsistency between the approaches of the lead ethics committee (LEC) and site-specific ethics committees in the way they deal with protocol amendments and adverse event governance, further compounding the delays in initial review. Five multicentre clinical trials are currently being conducted by the Palliative Care Clinical Studies Collaborative (PaCCSC),3 a national initiative to improve the evidence for symptom therapeutics at the end of life. Submissions for ethics review occurred between May 2008 and July 2009 across nine sites in five states. As in the study by Hicks et al,1 ethics review submissions included the NSW LEC, but because these submissions were more recent than those reported by Hicks et al, they were submitted on the National Ethics Application Form (NEAF). Hicks and colleagues state there is benefit in standard documentation, but using the NEAF does not reduce the need for collating complete sets of documentation for each site-specific approval and any subsequent amendments or adverse events.4 For the PaCCSC, LEC and site-specific review in NSW achieved approval in a median of 119 days (range, 76–209), compared with 107 days (range, 6–172) for individual committees in other states. Hicks and colleagues1 did not quantify the costs generated by these delays. Given that staff are often employed to prepare ethics submissions and then retained for the definitive study, additional delays in approval are costly, especially with finite, competitive grants funding. Costs of multisite ethics review applications have previously been quantified in Australia,2 but the additional delays in NSW from the requirement for site-specific approval are estimated to have cost the PaCCSC about $4000 per study per site in salaries and on-costs. Across three NSW sites and five studies, $55 000 has been spent without measurable ethical or research governance benefits. Theoretically, LEC review should streamline protocol amendments and adverse events reporting, as they are the responsibility of the LEC. But although protocol amendments are supposed to be reviewed only by the LEC, some site-specific committees continue to insist on approving all amendments.4 Efforts to consolidate adverse event reporting have made some progress.5 All adverse events are reported to the LEC for review, and any required response should be shared with site-specific committees. Again, some non-lead sites continue to insist on separately reviewing adverse events rather than using the LEC as intended.

Tania Shelby-James · Meera R Agar · David C Currow

Ethics 1 March 2010 Free

A case study evaluation of ethics review systems for multicentre clinical trials

To the Editor: Hicks and colleagues presented a study contrasting the ethics review system in two multicentre trials.1 They concluded that the introduction of a centralised ethics review process in New South Wales did not reduce the overall time taken to receive approval, but did help to reduce the time and resources involved in preparing applications. We are establishing a multicentre trial to prospectively evaluate and refine a model to predict patient outcomes after endovascular aortic aneurysm repair.2 This will involve collaboration between vascular surgeons at over 40 sites throughout Australia, one site in the United Kingdom and six sites in New Zealand. We, along with Hicks and colleagues, have experienced difficulty in establishing our multicentre trial. Multiple individual ethics applications have been submitted to human research ethics committees (HRECs) throughout Australia. The National Ethics Application Form (NEAF) was created to minimise inconsistencies and reduce the time and resources required when submitting ethics applications to multiple HRECs. Although the NEAF was designed to increase efficiency and quality,3 in reality it has done little to facilitate the submission process. It has been useful in NSW and Queensland, which have processes to allow the review of multicentre trials, but few HRECs in other Australian states accept the entire form, and often they have their own specific requirements. This has resulted in increased costs and time, as well as different interpretations of the trial protocol — effects that Hicks and colleagues found were reduced with a centralised ethics system. We are at least 9 months behind schedule in establishing our trial after having submitted over 25 individual applications. This has resulted in substantial losses in patient recruitment and research time. Other researchers have also reported on the excessive time and resources required to submit ethics applications.4 Like Hicks and colleagues (and no doubt other researchers), we are advocates of the Harmonisation of Multi-centre Ethical Review (HoMER) initiative.5 This national system would allow single ethics review that would be recognised by all institutions participating in a collaborative research project, without re-review by their institutional HREC. It is uncertain how many HRECs will adopt the HoMER initiative, but we remain optimistic that HoMER can solve problems that the NEAF has not. Central coordination of the ethics review process may help standardise documentation, as demonstrated by Hicks and colleagues, but clearly other factors, such as the time required for approval, need to be addressed.

Kate L Fitzpatrick · Margaret Boult · Robert A Fitridge

Ethics 1 March 2010 Free

A case study evaluation of ethics review systems for multicentre clinical trials

To the Editor: Hicks and colleagues are to be commended for reporting the benefits of the single ethics review system for multicentre trials in reducing the time taken for review, reducing unnecessary duplication of effort, and standardising documentation.1 They based their analysis on the overall time to approval, which included both an ethics and a governance component. The single ethics review model introduced by NSW Health in July 2007 separates scientific and ethics review from business or governance review (which requires site-specific approval). The Australian Research Ethics Database, developed by Infonetica for NSW Health, is used by the Cancer Institute NSW Clinical Research Ethics Committee (CREC) to track and manage multicentre research projects. It uses a 60-calendar-day clock to measure the time from submission to approval.2 The 60-day period sets a benchmark and represents a reasonable target review time. This clock stops, for example, when the CREC has sent a letter to the investigator and is awaiting a response. This method of measurement makes the total number of days for ethics review even shorter — for example, for the CO.20 trial described by Hicks and colleagues,1 the total number of days would be 66 rather than the 77 days they reported. It should be noted that if the CREC, which I chaired, sought changes to the participant information sheet after the first review of a research submission, the response was approved by the executive of the committee between full committee meetings. We used executive review more extensively than other committees to save time. This and other efficiencies, such as reducing the time between submission and the first ethics committee review and using a paperless review system, make it more likely that we will achieve a review time of less than 60 days as the committee becomes more experienced. This makes the adoption of a single ethics review system even more attractive.

Ian N Olver

Ethics 1 March 2010 Free

Winds of change: growing demands for transparency in the relationship between doctors and the pharmaceutical industry

To the Editor: Mitchell raises issues that strongly reflect on the professional standing of the medical profession.1 His particular focus is on the pharmaceutical industry, and on much needed changes as highlighted by Medicines Australia.2 Similar concerns exist in the medical technology industry where the transparency of relationships is becoming increasingly important. Mitchell highlights the fact that self-regulation by the medical profession has been largely ineffective.1 In this day of international corporate activity in the delivery of health care, the declaration of the Hippocratic Oath is no longer sufficient. The Royal Australasian College of Surgeons (RACS) published a code of conduct in 2006.3 This has been supplemented recently by the code of conduct of the Australian Medical Council.4 Separately, the Medical Technology Association of Australia has published its guidelines for industry groups.5 However, the dominant criticism of these documents is that compliance is voluntary. The RACS believes it is critical that the profession takes leadership in this complex issue to ensure that trust is maintained in the patient–doctor relationship. Consequently, we have recently expanded our code of conduct with a comprehensive policy dealing with interactions with the medical technology and pharmaceutical industries.6 We are introducing a sanctions policy to strengthen compliance. If there is a breach of the guidelines, the fellow or trainee concerned will need to confirm ongoing adherence to the RACS code of conduct. If there is a repeat offence, then cause will need to be given as to why the fellow should not have his or her fellowship removed or the trainee should not be dismissed from the training program. As professionals, these issues of integrity, transparency and trust are fundamental. The doctor–patient relationship must be our primary focus, and should not be violated by any perceived or real conflict of interest.

Ian R Gough · Ian Dickinson · Guy Maddern · Michael Grigg · David J Hillis

Ethics 1 March 2010 Free

Winds of change: growing demands for transparency in the relationship between doctors and the pharmaceutical industry

To the Editor: There is no doubt that the relationship between doctors and the pharmaceutical industry, described by Mitchell,1 is a complex one. Mitchell states that: “There are few, if any, analogies for the relationship between the medical profession and the pharmaceutical industry”.1 We contend that, as medical professionals are to the pharmaceutical industry, nutritional health professionals are to the food industry. Nutritional health professionals, like medical professionals, span the health care spectrum — from research and public health to tertiary care — and include doctors, dietitians, nutritionists and nurses. The food industry is more expansive than the pharmaceutical industry, encompassing primary producers, manufacturers, retailers and parts of the pharmaceutical industry. Some definitions include alcohol as part of the food industry. As well as this difference in magnitude, there are other substantial differences between the pharmaceutical and food industries. Contact between the food industry and health professionals is ubiquitous and unavoidable, but lacks the oversight provided by the, albeit voluntary, Medicines Australia code of conduct.2 It is unrealistic to suggest that health professionals should be completely divorced from the food industry. The alcohol industry is, however, the exception.3 Appropriate engagement between health professionals and the food industry has the potential to improve population health.4 Product reformulation (to improve the nutrient profile, such as reducing salt or fat content) and repackaging (to make smaller portions) are examples of successful partnerships between health professionals and the food industry. The food industry must work with health professionals to respond to consumer demand for healthier foods. Yet many of these foods are still of questionable nutritional quality, or of benefit only in very specific cases. Medications, on the other hand, must be proven before they enter the market. Finally, the food industry is able to advertise directly to the public and use health professionals to promote their products. This creates opportunities for endorsement — perceived or otherwise — of specific foods or brands by key opinion leaders, like doctors or sporting icons, who have varying degrees of nutritional expertise but are nevertheless viewed by the public as credible. Increasing rates of obesity legitimately prompt greater scrutiny of food industry activity. Analogous to the relationship between the pharmaceutical industry and doctors, it is equally necessary to “. . . expeditiously formalise a relationship of integrity and transparency . . .” between health professionals and the food industry.1 A code of conduct, equivalent to that of Medicines Australia, may be a necessary next step.

Iain S Pratt · Clare L Hughes · Terry J Slevin

Ethics 1 March 2010 Free

Winds of change: growing demands for transparency in the relationship between doctors and the pharmaceutical industry

To the Editor: In his article on the relationship between doctors and the pharmaceutical industry, Mitchell highlights moves to bring about greater transparency.1 While such moves are important, they do not go nearly far enough. Mitchell states that “it is not the relationship between medical practitioners and the pharmaceutical industry per se that is the problem, but how that relationship is enacted”.1 I disagree. The marketing activities of pharmaceutical companies are often justified by reference to the role that they play in the development of new medications, summarised in the statement “we need them”. In fact, the vast majority of the world’s most valuable medications were discovered and, in most cases, developed without pharmaceutical company involvement. Even recent advances, such as 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, originated with the brilliant work of researchers in the basic biological sciences.2 The progression from discovery to the development, testing and approval of a new drug does require large investments by pharmaceutical companies, but they do this for commercial reasons, in the hope of delivering profits to their shareholders. Naturally, they endeavour to promote their products and maximise their profits. As Mitchell outlines, their means include gifts, honoraria, sponsorship of events, “key opinion leaders” and “ghost writing”.1 As Mitchell also outlines, it is well established that all these manoeuvres are effective in altering doctors’ prescribing practices.1 Mitchell recommends that “we go down the route of disclosure of earnings from industry”.1 But is transparency enough? Is it enough to read that the keynote speaker at a symposium received an honorarium from a pharmaceutical company? Is it enough to know that delegates’ meals, entertainment or travel were paid for by a pharmaceutical company? Is it enough to know that your pen was provided by the manufacturer of X? (Isn’t that why the company’s name is written on it?) The fact that we need pharmaceutical companies to develop new drugs does not justify any of these activities, all intended to influence our decisions about whether and when to use their products. The fact that pharmaceutical companies cannot advertise or sell directly to their customers (ie, patients) in no way justifies marketing through intermediaries (ie, doctors and pharmacists). The recent report of the Association of American Medical Colleges is clear and forthright in proscribing many of these activities.3 Mitchell summarises their recommendations nicely, so I am surprised and disappointed that he does not go on to recommend proscription himself, rather than just transparency.

Richard Kelly Barnes

Making cars and making health care: a critical review

To the Editor: We read with some dismay the article by Winch and Henderson1 critically reviewing the introduction into health care of process improvement methods pioneered in manufacturing and service industries. We take issue with the article at several points. While the article is titled a “critical review”, it has more of the character of a personal view. For instance, the authors single out “lean thinking” for particular criticism, but the examples cited are in fact a mixture of business process re-engineering, hospital or health system restructuring, and total quality management. These differ substantially from lean thinking, but this is not acknowledged in the text. Then the authors claim that lean thinking has been accepted “somewhat uncritically”, but this is not so. The current peer-reviewed literature contains a number of articles critical of lean health care that have not been referenced by Winch and Henderson (for example, an article by Young and McClean2). The authors’ principal argument is that fragmentation of health care delivery reduces the quality of care provided. We agree. They then argue that process redesign increases the fragmentation and impairs quality of care, but we reject this view. The process redesign programs we have been involved with have been aimed at increasing the time that staff can spend with patients. They explicitly involve staff in designing systems that will deliver this. Rather than trying to “[reduce] the richness of professional health care practice to impoverished snippets of work”,1 we are trying to put broken care processes back together. The authors close by implying that process redesign may “add to the problems of hospital misadventure . . . rather than solve them”, but they provide no evidence for this assertion. In fact, the existing evidence points the opposite way. For example, a recent report from the ThedaCare group in the United States showed a reduction in mortality after coronary artery bypass grafting from 4% to effectively zero as a result of process improvement.3 Here in Australia, the Flinders Medical Centre in Adelaide has seen a striking reduction in serious adverse events after implementing a process redesign program based on lean thinking.4 Interest in process redesign is increasing in health care. All improvement methods benefit from critical discussion, but critiques that are also well supported by evidence are likely to be the most influential.

David I Ben-Tovim · Duncan Stuart · Maarten Kamp · Paul Cullen

Making cars and making health care: a critical review

To the Editor: As one who works in paediatrics and sees parents bringing their children to hospital for day surgery, and then taking them home again a few hours later, I concur with Winch and Henderson in their critique of “lean thinking” ways of delivering health care.1 Nowhere is this more obvious, and nowhere is it applied with less critical assessment, than in day admissions. This process, which we are told is best for families, may not be. It is best for the hospital, of course, as it means that care can be delivered for a fraction of the cost of keeping people in for several days. But is it best for families? What are we doing to parents when we send them home with a child fresh from surgery? While we might give them some education about what to do if the child has an adverse event, there is not enough time to make sure the parents have understood, are able to read effectively, and have taken any information on board (with their ability to do so potentially hampered by their state of anxiety). How do we know what the infection rates are after surgery? If the child develops an infection, the parents are likely to take the child to a general practitioner rather than return to the hospital, and busy GPs may not report back to the hospital on the child’s visit and the need for treatment. We do not ask parents what financial burden we are placing on them. Have they taken days off work or used their holiday time to look after the child? Does that mean financial hardship for the family? Do we ask them what emotional burden it is placing on them? As a highly educated health professional who knows the ropes, I can only imagine how anxious young parents must be with a child who has just had an operation and for whom there is no health care support at home. Of course, my comments about children are just as salient for adult day surgery admissions. I believe that lean thinking and its penultimate expression in health delivery, the day admission, should be critically re-examined, and there needs to be much more research on the immediate and long-term effects on patients and their families.

Linda E Shields

Making cars and making health care: a critical review

To the Editor: It is pleasing to see the acknowledgement by contributors of the fundamental premise that the fragmentation of health care may reduce the quality provided, which was a key argument of our article.1 Our aim was to provide space for critical appraisal of “lean thinking” and its application to health care, by questioning the assumed theoretical basis from which this approach is derived and enquiring about the evidence for long-term benefits relating to patient outcomes. We wished to engender discussion and debate rather than provide a systematic review of existing literature. To this end, we think our aim has been achieved. Returning to the central thesis of our article, we argue that the notion of quality is rapidly being subsumed by quantity (understood as patient throughput and the number of measurable errors). This is reflected in the focus of Ben-Tovim and colleagues on process rather than practice.2 We believe that medicine is grounded in the human condition,3 and thus ideas of quality must relate to patient experience, including harms that are not readily measurable. We acknowledge that health care is becoming more and more complex, and increasingly requires the exercise of practical wisdom that informs clinical reasoning.4 Individual differences between patients mean that each situation has to be considered in its own context. Recognition of this difference provides the opportunity for some of the richness and satisfaction inherent in medicine. Finally, medicine and health care are far from immune to adopting and repeating the mistakes of other professions and industries. It has been suggested that the continued rationalisation of health care, such as occurs with “lean” approaches, may contribute to the deprofessionalisation of medicine over time.5 In turn, this may promote the “McDonaldization”6 of health care, whereby efficient turnaround becomes the primary goal. We suspect that, while meeting a need at one level, this would provide little long-term satisfaction for health care providers or patients.

Sarah Winch · Amanda J Henderson

Book review

Ethics 1 March 2010 Free

Moral theory primer

Ethics in practice. Moral theory and the professions. Andrew Alexandra, Seumas Miller. Sydney: UNSW Press, 2009 (ix + 278 pp). ISBN 9781742230306. Most people who become interested in ethics or moral philosophy, I suspect, start with strong convictions about what is right or wrong in various individual instances, and then get to wondering what underlies these convictions, and whether they can be rationalised. Alexandra and Miller use this approach effectively in their book, Ethics in practice. The authors provide many literary and “real-life” case studies at the beginning of each chapter, to probe moral intuition, before exploring theories that have been advanced to make sense of morality, and the arguments for and against certain kinds of behaviour. This is not a comprehensive overview of moral philosophy; nor does it tackle any particular area of moral philosophy in great depth. Health professionals who have already significantly engaged in the biomedical ethics literature will probably find that there is not much new here (in fact, not much at all). Abortion and embryonic stem cell research are sidestepped altogether and end-of-life decisions are dealt with in a relatively brief discussion that focuses mainly on active euthanasia. However, possibly because it avoids these well worn areas, and addresses some often-neglected topics, I found this book refreshing. The morality of recreational drug use and its prohibition, filial responsibility, and corruption are enormous social issues that deservedly get attention. I found the chapter on professional role morality particularly useful and I intend to use some of its insights in my teaching of medical students. The book is written in a clear, balanced, analytical style that is easy to read, and assumes no prior knowledge. It is largely a “primer”, likely to be most appealing to those (from any background) with a budding interest in ethics and moral philosophy, who have done little reading previously — my 18-year-old daughter was immediately engaged. I think it will also interest those whose interest in ethics has hitherto been with specific “biomedical” issues who would like to start to read more widely.

Charles D Douglas

Correction

Endocrinology 1 March 2010 Free

AUSDRISK: an Australian Type 2 Diabetes Risk Assessment Tool based on demographic, lifestyle and simple anthropometric measures

Incorrect internet address. In “AUSDRISK: an Australian Type 2 Diabetes Risk Assessment Tool based on demographic, lifestyle and simple anthropometric measures” in the 15 February 2010 issue of the Journal (Med J Aust 2010; 192: 197-202), there was an error in the second-last paragraph of the Discussion (page 201). The internet address for the AUSDRISK patient-friendly questionnaire should have been <http://www.bakeridi.edu.au/aus_diabetes_risk>.

Lei Chen · Dianna J Magliano · Beverley Balkau · Stephen Colagiuri · Paul Z Zimmet · Andrew M Tonkin · Paul Mitchell · Patrick J Phillips · Jonathan E Shaw

Columns

1 March 2010 Free

In Other Journals

Numbers by colour What would you think someone would say to you if you told them that you saw numbers as colours? For example, that you see the number three as purple? On being told she was weird because she said her “numbers were colours”, one teenager didn’t mention it again, to anyone, for the next 25 years.1 However, in an editorial in the BMJ, US expert Eagleman says that synaesthesia — where stimulation of one area of the brain triggers an anomalous perceptual experience in another (usually separated) area of the brain — is a harmless neurological condition experienced by about 1% of the population.2 He describes synaesthesia as a fusion of different sensory perceptions: “the feel of sandpaper might evoke an F sharp, a symphony might be experienced in blues and golds, or the concept of February might be experienced above the right shoulder”. Synaesthetic experiences are not hallucinations; and synaesthetic perceptions are involuntary, automatic, and consistent over time, he said. The condition may have a genetic basis. 1. BMJ 2009; 339: b3191 2. BMJ 2010; 340: b4616 Defeating deformity What may the Roman emperor Claudius, the English poet Lord Byron and the international entertainer Dudley Moore have had in common with each other? Congenital talipes equinovarus or, in other words, a clubfoot. In the past, infants born with a clubfoot may have been subjected to various, often multiple, surgical procedures. Today, they are much more likely to be managed with the more successful Ponseti method, which consists of sequential plasters and prolonged bracing, with one or two minor surgical procedures included as required. In a review article, Bridgens and Kiely say that the earlier this treatment is started — ideally at around one or two weeks of age — the easier the correction will be. Detailed information about the Ponseti method is available online at www.ponseti.info and www.global-help.org BMJ 2010; 340: c355 Antibiotics for Buruli ulcer? The question of whether there is a role for antibiotics in the treatment of Buruli ulcer disease (Mycobacterium ulcerans infection) has now been answered with a resounding “yes”, according to an Australian expert. Johnson was commenting on a randomised controlled trial, conducted in Ghana and published in The Lancet, which found that antimycobacterial treatment with agents such as streptomycin, rifampicin and clarithromycin was effective in treating early, limited infection — without surgical debridement. For many years, surgical debridement alone was the standard treatment for Buruli ulcer disease; the addition of antimicrobial drugs to surgical treatment has only been recommended relatively recently. The researchers observed that healing of lesions continued long after antibiotic treatment had stopped. Johnson said that this slow response could have led earlier investigators to abandon antibiotics in favour of wide surgical excision. Further, paradoxical reactions during antibiotic treatment (where things look worse before they get much better) could also have contributed to the view that antibiotics were ineffective. (Lastly, “yes”, for those Australians who are wondering, — we have known Buruli ulcer as Bairnsdale ulcer.) Lancet Online 4 Jan 2010 Fish for thought Treatment with a natural substance may prevent, or at least delay, the onset of psychotic disorder in at-risk adolescents and young adults, say a team of Austrian and Australian researchers (including Australian of the Year, Professor Patrick McGorry). In a randomised, placebo-controlled trial, Amminger and colleagues found that daily capsules of concentrated marine fish oil taken for a period of 12 weeks significantly reduced the risk of progression to psychosis in subjects at ultra-high risk of psychotic disorder. Further, the effect was sustained at one year — well after the intervention had ceased. Long-chain omega-3 polyunsaturated fatty acids (PUFAs) are key components of the oil, and are thought to have neuroprotective effects. The researchers say taking the fish oil could present an appealing alternative to using antipsychotic medications in the prodromal phase of psychotic illness. The adverse effects of using antipsychotics can include metabolic changes, sexual dysfunction and weight gain, whereas omega-3 PUFAs are thought to be very safe, with few clinically relevant adverse effects, except for some gastrointestinal symptoms that may occur, like nausea, loose stools and fishy eructation. Arch Gen Psychiatry 2010; 67: 146-154

Ann Gregory

Next Issue Volume 192 Issue 6

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Cover 150310
From the editor’s desk 15 March 2010 Free

Rationing versus increased taxes

Martin B Van Der Weyden

From the editor’s desk 15 March 2010 Free

In This Issue

Ruth Armstrong

Editorials 15 March 2010 Free

Congenital anomalies — why bother?

Carol I Bower MB BS, PhD, FAFPHM · David Lester-Smith BM BS, FRACP, MPH · Elizabeth J Elliott MD, MPhil, FRACP

Editorials 15 March 2010 Free

Vertebroplasty, evidence and professional protest

Martin B Van Der Weyden MD, FRACP, FRCPA

Previous Issue Volume 192 Issue 4

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Cover 150210
From the editor’s desk 15 February 2010 Free

Troubles in Alberta health: deja vu

Martin B Van Der Weyden

From the editor’s desk 15 February 2010 Free

In This Issue

Ruth Armstrong

Editorials 15 February 2010 Free

Improving use of medicines with clinician-led use of validated clinical indicators

Jocelyn S Lowinger BSc(Med), MB BS(Hons), GradCertPublHlth · Helen E Stark BPharm, MBA · Maria Kelly BPharm, DipEd, GradCertBioethics · Clifford F Hughes AO, FRACS, FACC, FACS · Madlen Gazarian MB BS(Hons), MSc(ClinEpi), FRACP · Karen I Kaye BPharm, DipHospPharm, GradCertPharmacoecon

Editorials 15 February 2010 Free

Identifying the pathways to suicide in child sexual abuse victims

Ross S Kalucy FRANZCP, FRACP, FRCPsych

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